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CompletedNCT01492101BEACONUpdated Jun 1, 2021Results posted

The BEACON Study (Breast Cancer Outcomes With NKTR-102)

A Phase 3 interventional study of NKTR-102 and Treatment of Physician's Choice (TPC) in Locally Recurrent Breast Cancer and Metastatic Breast Cancer, sponsored by Nektar Therapeutics. Completed at 153 sites in 11 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-01.

Sponsored by Nektar Therapeutics · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
852
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.

02

Conditions studied

  • Locally Recurrent Breast Cancer
  • Metastatic Breast Cancer

Browse trials for

03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 852 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Nektar Therapeutics is the lead sponsor of 39 studies on the registry; 2 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 12 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated
  • Patient can have either measurable or non-measurable disease by RECIST.
  • Patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine
  • Patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. A minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. All therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hematopoietic, liver and kidney functions.

Exclusion criteria

Exclusion Criteria (major highlights):

  • Patient with chemotherapy within 21 days, radiotherapy within 14 days, biological therapy with 14 days, hormonal therapy within 7 days and investigational therapy within 21 days prior to randomization.
  • Patient with any major surgery within 28 days prior to randomization.
  • Patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).
  • Patient with prior treatment for cancer with a camptothecin derivative.
  • Patient with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.
  • Patient received pharmacotherapy for hepatitis B or C, tuberculosis or HIV.
  • Patient with known cirrhosis diagnosed with Child-PUGH Class A or higher liver disease.
  • Patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.
  • Patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.
  • Patients with significant cardiovascular impairment.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
852 participants (actual)

Study arms

  • Experimental
    NKTR-102

    Drug: NKTR-102

  • Active comparator
    Physician's Treatment of Choice

    Drug: Treatment of Physician's Choice (TPC)

Interventions

  • DrugNKTR-102

    145 mg/m2 NKTR-102 will be delivered q21day as a 90-minute intravenous (IV) infusion on day 1 of each treatment cycle.

  • DrugTreatment of Physician's Choice (TPC)

    One of the following Treatment of Physician Choice will be administered per standard of care: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel

06

What researchers measure

Primary outcomes

  1. Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population

    Duration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.

    Time frame: 36 Months

Secondary outcomes

  1. Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population

    PFS was defined as the time from the date of randomization to the earliest date of disease progression (assessed by the investigator according to RECIST version 1.1) or death due to any cause. PFS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. For subjects whose disease did not progress or who did not die, the PFS time was censored at the time of the last tumor assessment that demonstrated lack of disease progression. For subjects who received new anti-cancer therapy, the PFS time was censored at the start of the new anti-cancer therapy.

    Time frame: Up to 38 months.

  2. Clinical Benefit Rate (CBR): ITT Population

    CBR was defined as the proportion of subjects with a CR, PR, or stable disease (SD) for at least 6 months (≥ 182 days).

    Time frame: Up to 38 months.

  3. Duration of Response (DOR): Efficacy Evaluable Population

    DOR was defined as the time from first documented CR or PR until the earliest evidence of disease progression or death from any cause. Subjects who were alive without documented disease progression per RECIST version 1.1 were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease.

    Time frame: Up to 38 months.

  4. Incidence of Dose Reductions: Safety Population

    Proportion of subjects who had a reduction in dose.

    Time frame: Up to 38 months.

  5. Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population

    The QLQ-C30 is composed of 5 multi-item functional scales (physical, role, social, emotional and cognitive functioning), a global health status/QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (financial impact, appetite loss, diarrhoea, constipation, insomnia and dyspnoea). Most items are scaled 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) except the items contributing to the global health status/QoL, which are 7-point questions (1 = very poor to 7 = excellent). Raw scores were transformed using a linear transformation to standardize the results so that scores range from 0 to 100. n=number of subjects who completed each individual scale. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

    Time frame: Up to 39 months

  6. QLQ-C30 Individual Scale, Change Over Time: ITT Population

    The QLQ-C30 is composed of 5 multi-item functional scales (physical, role, social, emotional and cognitive functioning), a global health status/QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (financial impact, appetite loss, diarrhea, constipation, insomnia and dyspnea). Most items are scaled 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) except the items contributing to the global health status/QoL, which are 7-point questions (from 1 = very poor to 7 = excellent). Raw scores were transformed using a linear transformation to standardize the results so that scores range from 0 to 100. n=number of subjects who completed each individual scale. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

    Time frame: From Baseline to Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56.

  7. Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population

    The QLQ-BR23 incorporates 5 multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning, and 3 single items to assess sexual enjoyment, upset by hair loss and future perspective. Most items were scaled one to four except the items contributing to the global health status/QoL, which were seven-point questions. Raw scores were transformed using a linear transformation to standardize the results so that scores ranged from 0-100. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

    Time frame: Baseline

  8. BR23 Score Change Over Time: ITT Population

    The QLQ-BR23 incorporates 5 multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning, and 3 single items assess sexual enjoyment, upset by hair loss and future perspective. Most items were scaled one to four except the items contributing to the global health status/QoL, which were seven-point questions. Raw scores were transformed using a linear transformation to standardize the results so that scores ranged from 0-100. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

    Time frame: Up to 38 months.

  9. Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]

    Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population pharmacokinetic (PK) model-derived mean AUC values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution.

    Time frame: Up to 38 months.

  10. Population Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26]

    Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population PK model-derived mean Cmax values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution.

    Time frame: Up to 38 months.

  11. Population Mean ± SD Elimination Half-life (t½) for NKTR-102 After Multiple Administration of 145 mg/m^2 NKTR-102 [27]

    Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population PK model-derived mean t½ values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution. The t½ of all analytes was primarily driven by NKTR-102. Thus, the NKTR-102 t½ of 37 days also applies to all NKTR-102 metabolites.

    Time frame: Up to 38 months.

  12. Objective Response Rate (ORR): Efficacy Evaluable Population

    ORR was defined as the proportion of subjects with a complete response (CR) or a partial response (PR), assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 The analyses were performed for subjects in the efficacy evaluable population who had measurable disease as determined by the investigator at baseline.

    Time frame: Up to 38 months.

07

Results

Posted Jun 1, 2021

Participant flow

Participant flow — Overall Study
MilestoneNKTR-102Physician's Treatment of Choice
Started429423
Completed9281
Not completed337342
Withdrew: Death323322
Withdrew: Withdrawal by subject1418
Withdrew: Lost to follow-up02

Outcome measures

PrimaryKaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population

Duration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.

Time frame:
36 Months
Reported as:
Median · Months
Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population
MonthsNKTR-102Physician's Treatment of Choice
Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population12.4 (11.0 to 13.6)10.3 (9.0 to 11.3)
Statistical analysis
  • NKTR-102 vs Physician's Treatment of Choice · Log Rank · p = = 0.0835 · Hazard ratio, log: 0.872 · 95% CI 0.747 to 1.019
SecondaryKaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population

PFS was defined as the time from the date of randomization to the earliest date of disease progression (assessed by the investigator according to RECIST version 1.1) or death due to any cause. PFS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. For subjects whose disease did not progress or who did not die, the PFS time was censored at the time of the last tumor assessment that demonstrated lack of disease progression. For subjects who received new anti-cancer therapy, the PFS time was censored at the start of the new anti-cancer therapy.

Time frame:
Up to 38 months.
Reported as:
Median · Months
Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population
MonthsNKTR-102Physician's Treatment of Choice
Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population2.4 (2.1 to 3.5)2.8 (2.1 to 3.5)
Statistical analysis
  • NKTR-102 vs Physician's Treatment of Choice · Log Rank · p = = 0.3017 · Hazard ratio (hr): 0.926 · 95% CI 0.798 to 1.075
SecondaryClinical Benefit Rate (CBR): ITT Population

CBR was defined as the proportion of subjects with a CR, PR, or stable disease (SD) for at least 6 months (≥ 182 days).

Time frame:
Up to 38 months.
Reported as:
Number · percentage of subjects
Clinical Benefit Rate (CBR): ITT Population
percentage of subjectsNKTR-102Physician's Treatment of Choice
Clinical Benefit Rate (CBR): ITT Population20.5 (16.8 to 24.6)19.6 (15.9 to 23.7)
SecondaryDuration of Response (DOR): Efficacy Evaluable Population

DOR was defined as the time from first documented CR or PR until the earliest evidence of disease progression or death from any cause. Subjects who were alive without documented disease progression per RECIST version 1.1 were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease.

Time frame:
Up to 38 months.
Reported as:
Median · Months
Duration of Response (DOR): Efficacy Evaluable Population
MonthsNKTR-102Physician's Treatment of Choice
Duration of Response (DOR): Efficacy Evaluable Population3.9 (3.5 to 5.1)3.7 (2.1 to 3.9)
SecondaryIncidence of Dose Reductions: Safety Population

Proportion of subjects who had a reduction in dose.

Time frame:
Up to 38 months.
Reported as:
Number · percentage of subjects
Incidence of Dose Reductions: Safety Population
percentage of subjectsNKTR-102Physician's Treatment of Choice
Incidence of Dose Reductions: Safety Population27.528.3
SecondaryQuality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population

The QLQ-C30 is composed of 5 multi-item functional scales (physical, role, social, emotional and cognitive functioning), a global health status/QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (financial impact, appetite loss, diarrhoea, constipation, insomnia and dyspnoea). Most items are scaled 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) except the items contributing to the global health status/QoL, which are 7-point questions (1 = very poor to 7 = excellent). Raw scores were transformed using a linear transformation to standardize the results so that scores range from 0 to 100. n=number of subjects who completed each individual scale. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

Time frame:
Up to 39 months
Reported as:
Mean · units on a scale
Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population
units on a scaleNKTR-102Physician's Treatment of Choice
Global health status/QoL61.4 ± 21.7658.0 ± 20.43
Physical functioning74.5 ± 19.7272.3 ± 19.74
Role functioning71.8 ± 26.8167.3 ± 26.93
Emotional functioning72.4 ± 21.8671.9 ± 20.06
Cognitive functioning82.5 ± 18.781.2 ± 19.04
Social functioning73.0 ± 26.6971.0 ± 25.06
Fatigue37.7 ± 23.6841.3 ± 22.98
Nausea and vomiting8.6 ± 13.399.9 ± 16.17
Pain32.3 ± 27.235.3 ± 28.01
Dyspnoea24.5 ± 27.4423.6 ± 26.2
Insomnia29.3 ± 28.9431.5 ± 27.11
Appetite loss24.3 ± 27.5526.6 ± 27.89
Constipation18.0 ± 25.921.0 ± 28.15
Diarrhoea6.3 ± 13.645.6 ± 11.14
Financial difficulties26.4 ± 31.2921.9 ± 28.95
SecondaryQLQ-C30 Individual Scale, Change Over Time: ITT Population

The QLQ-C30 is composed of 5 multi-item functional scales (physical, role, social, emotional and cognitive functioning), a global health status/QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (financial impact, appetite loss, diarrhea, constipation, insomnia and dyspnea). Most items are scaled 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) except the items contributing to the global health status/QoL, which are 7-point questions (from 1 = very poor to 7 = excellent). Raw scores were transformed using a linear transformation to standardize the results so that scores range from 0 to 100. n=number of subjects who completed each individual scale. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

Time frame:
From Baseline to Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56.
Reported as:
Mean · units on a scale
QLQ-C30 Individual Scale, Change Over Time: ITT Population
units on a scaleNKTR-102Physician's Treatment of Choice
Global health status/QoL: Week 8-4.4 ± 22.57-4.7 ± 20.37
Global health status/QoL: Week 16-2.5 ± 22.9-5.6 ± 21.86
Global health status/QoL: Week 24-1.8 ± 24.99-6.6 ± 22.47
Global health status/QoL: Week 32-0.2 ± 20.39-6.3 ± 26.66
Global health status/QoL: Week 40-5.2 ± 22.27-2.6 ± 19.41
Global health status/QoL: Week 48-2.3 ± 18.62-1.8 ± 20.71
Global health status/QoL: Week 562.9 ± 17.79-11.1 ± 29.36
Physical functioning: Week 8-4.9 ± 17.98-7.1 ± 17.4
Physical functioning: Week 16-3.0 ± 20.63-7.0 ± 18.26
Physical functioning: Week 240.3 ± 20.93-4.7 ± 15.9
Physical functioning: Week 32-3.0 ± 18.88-8.5 ± 20.4
Physical functioning: Week 40-1.9 ± 19.23-6.4 ± 18.81
Physical functioning: Week 480.2 ± 17.66-7.4 ± 16.46
Physical functioning: Week 562.2 ± 13.48-10.4 ± 24.27
Role functioning: Week 8-6.6 ± 27.26-8.3 ± 27.37
Role functioning: Week 16-4.8 ± 26.06-8.3 ± 24.41
Role functioning: Week 24-7.8 ± 33.3-10.8 ± 26.72
Role functioning: Week 32-9.7 ± 19.03-12.2 ± 29.81
Role functioning: Week 40-8.7 ± 30.94-7.8 ± 27.93
Role functioning: Week 48-3.1 ± 25.38-5.7 ± 21.7
Role functioning: Week 56-2.6 ± 17.12-9.4 ± 35.08
Emotional functioning: Week 8-0.5 ± 19.65-2.0 ± 19.95
Emotional functioning: Week 162.7 ± 18.93-1.6 ± 20.57
Emotional functioning: Week 24-0.6 ± 22.34-3.7 ± 18.95
Emotional functioning: Week 32-2.8 ± 21.02-7.6 ± 20.88
Emotional functioning: Week 40-1.4 ± 26.120.8 ± 19.11
Emotional functioning: Week 480.9 ± 21.371.2 ± 18.83
Emotional functioning: Week 56-3.6 ± 19.72-4.7 ± 25.29
Cognitive functioning: Week 8-3.3 ± 18.46-3.2 ± 19.44
Cognitive functioning: Week 16-1.4 ± 17.67-4.4 ± 20.81
Cognitive functioning: Week 24-1.8 ± 17.26-2.2 ± 17.12
Cognitive functioning: Week 32-4.6 ± 17.82-7.9 ± 20.14
Cognitive functioning: Week 40-5.7 ± 18.61-3.5 ± 21.6
Cognitive functioning: Week 48-4.6 ± 18.042.2 ± 17.75
Cognitive functioning: Week 56-2.9 ± 18.25-6.7 ± 22.97
Social functioning: Week 8-4.9 ± 27.46-6.2 ± 24.04
Social functioning: Week 160.4 ± 27.57-6.4 ± 24.2
Social functioning: Week 24-3.4 ± 25.68-7.2 ± 24.1
Social functioning: Week 32-8.8 ± 20.61-7.2 ± 30.1
Social functioning: Week 40-9.7 ± 26.09-7.0 ± 20.98
Social functioning: Week 48-5.5 ± 17.86-6.6 ± 20.71
Social functioning: Week 56-3.2 ± 22.25-24.4 ± 29.96
Fatigue: Week 86.7 ± 22.886.6 ± 22.17
Fatigue: Week 163.7 ± 22.637.7 ± 22.84
Fatigue: Week 243.0 ± 26.513.6 ± 21.23
Fatigue: Week 325.0 ± 21.846.6 ± 24.25
Fatigue: Week 404.1 ± 26.652.3 ± 19.02
Fatigue: Week 480.9 ± 18.696.7 ± 14.53
Fatigue: Week 562.1 ± 19.574.5 ± 24.36
Nausea and vomiting: Week 812.8 ± 23.284.2 ± 21.94
Nausea and vomiting: Week 168.8 ± 19.85-2.0 ± 19.1
Nausea and vomiting: Week 247.2 ± 22.57-0.1 ± 16.55
Nausea and vomiting: Week 326.5 ± 14.213.5 ± 18.81
Nausea and vomiting: Week 404.5 ± 12.975.6 ± 23.61
Nausea and vomiting: Week 485.0 ± 13.773.9 ± 28.92
Nausea and vomiting: Week 568.0 ± 11.661.6 ± 23.02
Pain: Week 8-1.7 ± 26.082.4 ± 27.03
Pain: Week 16-5.0 ± 26.91.9 ± 27.8
Pain: Week 24-4.1 ± 29.352.1 ± 27.78
Pain: Week 32-1.0 ± 27.173.9 ± 32.49
Pain: Week 401.6 ± 31.821.3 ± 29.96
Pain: Week 48-0.8 ± 30.82-0.4 ± 25.23
Pain: Week 56-4.2 ± 22.880.5 ± 33.95
Dyspnoea: Week 80.7 ± 25.025.8 ± 24.59
Dyspnoea: Week 16-1.1 ± 26.344.6 ± 26.99
Dyspnoea: Week 24-2.0 ± 25.651.4 ± 20.47
Dyspnoea: Week 320 ± 24.778.6 ± 29.67
Dyspnoea: Week 402.4 ± 27.935.0 ± 25.95
Dyspnoea: Week 48-5.6 ± 26.38-0.9 ± 19.62
Dyspnoea: Week 56-7.1 ± 18.36-1.2 ± 22.13
Insomnia: Week 8-1.5 ± 28.13.3 ± 30.28
Insomnia: Week 16-1.4 ± 24.42.1 ± 27.2
Insomnia: Week 24-2.7 ± 31.771.3 ± 26.41
Insomnia: Week 321.5 ± 34.042.5 ± 30.14
Insomnia: Week 400 ± 31.514.4 ± 22.71
Insomnia: Week 482.8 ± 28.050.9 ± 34.01
Insomnia: Week 56-1.3 ± 35.57-1.0 ± 27.53
Appetite loss: Week 811.6 ± 32.034.0 ± 30.26
Appetite loss: Week 169.4 ± 32.16-2.1 ± 29.75
Appetite loss: Week 244.6 ± 36.55-1.6 ± 30.57
Appetite loss: Week 328.9 ± 35.420 ± 32.04
Appetite loss: Week 406.9 ± 38.575.4 ± 38.58
Appetite loss: Week 482.2 ± 34.6713.0 ± 45.93
Appetite loss: Week 5614.7 ± 35.381.0 ± 39.19
Constipation: Week 82.1 ± 29.956.7 ± 27.81
Constipation: Week 160.2 ± 31.033.1 ± 30.96
Constipation: Week 240.5 ± 29.65-2.0 ± 28.14
Constipation: Week 324.6 ± 29.830.3 ± 26.53
Constipation: Week 401.0 ± 28.44-3.2 ± 29.32
Constipation: Week 48-0.6 ± 31.657.0 ± 33.48
Constipation: Week 561.9 ± 34.42-4.4 ± 35.34
Diarrhoea: Week 810.2 ± 27.981.8 ± 16.87
Diarrhoea: Week 1610.8 ± 26.973.4 ± 19.07
Diarrhoea: Week 249.4 ± 26.432.4 ± 16.39
Diarrhoea: Week 329.2 ± 21.30.8 ± 17.07
Diarrhoea: Week 408.3 ± 23.067.8 ± 27.93
Diarrhoea: Week 4812.1 ± 22.230 ± 17.57
Diarrhoea: Week 564.5 ± 14.576.7 ± 31.37
Financial difficulties: Week 8-0.7 ± 22.870.6 ± 22.42
Financial difficulties: Week 160.8 ± 23.261.0 ± 22.48
Financial difficulties: Week 241.0 ± 21.094.6 ± 28.38
Financial difficulties: Week 321.2 ± 20.2810.2 ± 26.81
Financial difficulties: Week 404.2 ± 21.61-1.7 ± 19.74
Financial difficulties: Week 480 ± 22.273.5 ± 18.9
Financial difficulties: Week 56-1.9 ± 21.255.6 ± 25.72
Statistical analysis
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.635 · Mean difference (final values): 0.8 · 95% CI -2.65 to 4.33
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.1656 · Mean difference (final values): 2.1 · 95% CI -0.88 to 5.14
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.8356 · Median difference (final values): 0.5 · 95% CI -3.9 to 4.82
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.7727 · Mean difference (final values): 0.5 · 95% CI -2.88 to 3.88
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.7446 · Mean difference (final values): 0.5 · 95% CI -2.56 to 3.59
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.9169 · Mean difference (final values): 0.2 · 95% CI -4.0 to 4.45
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.9731 · Mean difference (final values): 0.1 · 95% CI -3.66 to 3.79
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = <0.0001 · Mean difference (final values): 7.3 · 95% CI 3.88 to 10.67
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.1252 · Mean difference (final values): -2.8 · 95% CI -7.59 to 0.93
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.1717 · Mean difference (final values): -2.8 · 95% CI -6.83 to 1.22
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.5513 · Mean difference (final values): -1.4 · 95% CI -5.95 to 3.18
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.0009 · Mean difference (final values): 8.6 · 95% CI 3.57 to 13.72
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.2337 · Mean difference (final values): -2.8 · 95% CI -7.35 to 1.8
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = <0.0001 · Mean difference (final values): 10.3 · 95% CI 6.6 to 13.98
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.99 · Mean difference (final values): 0 · 95% CI -3.74 to 3.69
SecondaryQuality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population

The QLQ-BR23 incorporates 5 multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning, and 3 single items to assess sexual enjoyment, upset by hair loss and future perspective. Most items were scaled one to four except the items contributing to the global health status/QoL, which were seven-point questions. Raw scores were transformed using a linear transformation to standardize the results so that scores ranged from 0-100. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

Time frame:
Baseline
Reported as:
Mean · units on a scale
Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population
units on a scaleNKTR-102Physician's Treatment of Choice
Body image69.5 ± 28.9469.9 ± 27.91
Sexual functioning14.1 ± 19.2413.3 ± 18.91
Sexual enjoyment36.1 ± 29.2534.2 ± 30.77
Future perspective38.7 ± 30.5336.1 ± 29.0
Systemic therapy side effects21.9 ± 16.3722.3 ± 15.15
Breast symptoms15.3 ± 21.5515.8 ± 20.79
Arm symptoms20.8 ± 23.422.2 ± 22.75
Upset by hair loss33.2 ± 34.1530.5 ± 33.29
SecondaryBR23 Score Change Over Time: ITT Population

The QLQ-BR23 incorporates 5 multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning, and 3 single items assess sexual enjoyment, upset by hair loss and future perspective. Most items were scaled one to four except the items contributing to the global health status/QoL, which were seven-point questions. Raw scores were transformed using a linear transformation to standardize the results so that scores ranged from 0-100. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

Time frame:
Up to 38 months.
Reported as:
Mean · units on a scale
BR23 Score Change Over Time: ITT Population
units on a scaleNKTR-102Physician's Treatment of Choice
Body image: Week 8-0.8 ± 21.99-2.2 ± 20.49
Body image: Week 16-0.8 ± 24.31-2.3 ± 20.91
Body image: Week 240.8 ± 23.58-4.7 ± 20.97
Body image: Week 32-1.2 ± 26.27-0.3 ± 22.23
Body image: Week 403.3 ± 22.63-2.4 ± 20.98
Body image: Week 48-0.3 ± 25.47-1.1 ± 28.93
Body image: Week 563.9 ± 25.53-10.2 ± 26.61
Sexual functioning: Week 8-0.8 ± 16.07-2.2 ± 16.26
Sexual functioning: Week 160.1 ± 16.67-0.8 ± 17.28
Sexual functioning: Week 24-2.8 ± 16.72-1.4 ± 15.7
Sexual functioning: Week 32-2.2 ± 19.12-.7 ± 12.82
Sexual functioning: Week 40-5.4 ± 16.662.7 ± 16.27
Sexual functioning: Week 48-9.6 ± 19.681.6 ± 15.88
Sexual functioning: Week 56-5.3 ± 17.331.7 ± 13.06
Sexual enjoyment: Week 82.6 ± 19.84-4.2 ± 23.64
Sexual enjoyment: Week 16-0.3 ± 18.41-8.6 ± 21.7
Sexual enjoyment: Week 241.9 ± 29.72-3.5 ± 28.1
Sexual enjoyment: Week 322.0 ± 23.48-2.6 ± 20.24
Sexual enjoyment: Week 40-15.3 ± 29.697.1 ± 13.11
Sexual enjoyment: Week 48-27.8 ± 25.096.7 ± 14.91
Sexual enjoyment: Week 56-9.8 ± 16.270 ± 0
Future perspective: Week 83.5 ± 28.31.5 ± 27.21
Future perspective: Week 166.9 ± 27.173.6 ± 29.18
Future perspective: Week 249.3 ± 31.16.6 ± 29.55
Future perspective: Week 326.1 ± 30.194.4 ± 35.86
Future perspective: Week 407.1 ± 28.0513.3 ± 37.75
Future perspective: Week 489.2 ± 27.316.1 ± 35.66
Future perspective: Week 5616.0 ± 28.25-3.1 ± 45.22
Systemic therapy side effects: Week 82.3 ± 13.747.9 ± 16.03
Systemic therapy side effects: Week 163.0 ± 14.959.1 ± 17.7
Systemic therapy side effects: Week 242.2 ± 15.556.9 ± 17.39
Systemic therapy side effects: Week 323.5 ± 13.57.3 ± 18.01
Systemic therapy side effects: Week 403.2 ± 16.6210.1 ± 18.33
Systemic therapy side effects: Week 480.3 ± 11.746.4 ± 15.68
Systemic therapy side effects: Week 56-1.1 ± 11.066.8 ± 21.84
Breast symptoms: Week 8-1.7 ± 15.21-0.2 ± 13.82
Breast symptoms: Week 16-3.5 ± 14.60.1 ± 14.64
Breast symptoms: Week 24-4.8 ± 10.52-1.1 ± 13.48
Breast symptoms: Week 32-2.5 ± 14.26-2.8 ± 13.63
Breast symptoms: Week 40-1.9 ± 14.59-0.2 ± 11.02
Breast symptoms: Week 48-2.7 ± 12.160 ± 13.79
Breast symptoms: Week 56-3.4 ± 13.282.5 ± 12.15
Arm symptoms: Week 8-3.0 ± 16.72-0.9 ± 15.01
Arm symptoms: Week 16-5.1 ± 17.241.1 ± 18.24
Arm symptoms: Week 24-4.9 ± 20.06-0.3 ± 19.56
Arm symptoms: Week 32-4.4 ± 18.39-0.5 ± 19.03
Arm symptoms: Week 40-6.0 ± 21.865.2 ± 18.39
Arm symptoms: Week 48-5.6 ± 20.89-1.4 ± 12.98
Arm symptoms: Week 56-5.6 ± 19.44-1.4 ± 12.98
Upset by hair loss: Week 8-4.7 ± 32.280.1 ± 28.63
Upset by hair loss: Week 168.3 ± 33.612.9 ± 31.24
Upset by hair loss: Week 246.8 ± 35.023.5 ± 30.3
Upset by hair loss: Week 326.9 ± 31.76-2.3 ± 29.68
Upset by hair loss: Week 40-4.2 ± 30.0520.2 ± 29.37
Upset by hair loss: Week 48-16.7 ± 31.9121.7 ± 36.89
Upset by hair loss: Week 56-14.6 ± 30.1316.7 ± 44.1
Statistical analysis
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.5833 · Mean difference (final values): 0.9 · 95% CI -2.42 to 4.29
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.3098 · Mean difference (final values): 1.3 · 95% CI -1.24 to 3.9
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.6264 · Mean difference (final values): 1.1 · 95% CI -3.39 to 5.63
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.0003 · Mean difference (final values): -4.6 · 95% CI -7.11 to -2.1
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.2473 · Mean difference (final values): -1.4 · 95% CI -3.84 to 0.99
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.0333 · Mean difference (final values): -2.9 · 95% CI -5.54 to -0.23
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.2575 · Mean difference (final values): -4.5 · 95% CI -12.2 to 3.28
  • NKTR-102 vs Physician's Treatment of Choice · F-test · p = 0.1072 · Mean difference (final values): 5.6 · 95% CI -1.22 to 12.34
SecondaryPopulation Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]

Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population pharmacokinetic (PK) model-derived mean AUC values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution.

Time frame:
Up to 38 months.
Reported as:
Mean · μg·h/mL
Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]
μg·h/mLNKTR-102
NKTR-1024619 ± 4874
Irinotecan18.8 ± 22.1
SN385.32 ± 6.74
SN38G40.6 ± 39.2
APC4.0 ± 5.1
SecondaryPopulation Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26]

Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population PK model-derived mean Cmax values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution.

Time frame:
Up to 38 months.
Reported as:
Mean · ng/mL
Population Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26]
ng/mLNKTR-102
NKTR-10262701 ± 14576
Irinotecan138 ± 61.8
SN384.45 ± 1.82
SN38G47.7 ± 43.1
APC7.3 ± 6.7
SecondaryPopulation Mean ± SD Elimination Half-life (t½) for NKTR-102 After Multiple Administration of 145 mg/m^2 NKTR-102 [27]

Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population PK model-derived mean t½ values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution. The t½ of all analytes was primarily driven by NKTR-102. Thus, the NKTR-102 t½ of 37 days also applies to all NKTR-102 metabolites.

Time frame:
Up to 38 months.
Reported as:
Mean · days
Population Mean ± SD Elimination Half-life (t½) for NKTR-102 After Multiple Administration of 145 mg/m^2 NKTR-102 [27]
daysNKTR-102
Population Mean ± SD Elimination Half-life (t½) for NKTR-102 After Multiple Administration of 145 mg/m^2 NKTR-102 [27]36.8 ± 1.4
SecondaryObjective Response Rate (ORR): Efficacy Evaluable Population

ORR was defined as the proportion of subjects with a complete response (CR) or a partial response (PR), assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 The analyses were performed for subjects in the efficacy evaluable population who had measurable disease as determined by the investigator at baseline.

Time frame:
Up to 38 months.
Reported as:
Number · percentage of subjects
Objective Response Rate (ORR): Efficacy Evaluable Population
percentage of subjectsNKTR-102Physician's Treatment of Choice
Objective Response Rate (ORR): Efficacy Evaluable Population16.4 (12.7 to 20.7)17.0 (13.3 to 21.3)

Adverse events

Collected over Up to 38 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NKTR-102323/425 (76%)128/425 (30.1%)417/425 (98.1%)
Physician's Treatment of Choice322/406 (79.3%)129/406 (31.8%)404/406 (99.5%)
Most frequent serious events
Showing 10 of 170
Most frequent serious events
EventNKTR-102Physician's Treatment of Choice
Pleural effusionRespiratory, thoracic and mediastinal disorders15/42518/406
DiarrhoeaGastrointestinal disorders17/4252/406
Metastases to central nervous systemNeoplasms benign, malignant and unspecified (incl cysts and polyps)6/42510/406
VomitingGastrointestinal disorders10/4256/406
DehydrationMetabolism and nutrition disorders8/4256/406
DyspnoeaRespiratory, thoracic and mediastinal disorders2/4257/406
Febrile neutropeniaBlood and lymphatic system disorders2/4256/406
PyrexiaGeneral disorders3/4255/406
Respiratory failureRespiratory, thoracic and mediastinal disorders1/4255/406
AscitesGastrointestinal disorders4/4255/406
Most frequent other events
Showing 10 of 40
Most frequent other events
EventNKTR-102Physician's Treatment of Choice
DiarrhoeaGastrointestinal disorders277/42579/406
NauseaGastrointestinal disorders255/425155/406
VomitingGastrointestinal disorders172/42572/406
FatigueGeneral disorders145/425130/406
NeutropeniaBlood and lymphatic system disorders92/425126/406
ConstipationGastrointestinal disorders112/425126/406
Decreased appetiteMetabolism and nutrition disorders130/42598/406
AstheniaGeneral disorders91/425114/406
AlopeciaSkin and subcutaneous tissue disorders44/42595/406
Abdominal painGastrointestinal disorders89/42547/406

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)NKTR-102Physician's Treatment of ChoiceTotal
<=18 years000
Between 18 and 65 years341342683
>=65 years8881169
Age, Continuous
Age, Continuous(years)NKTR-102Physician's Treatment of ChoiceTotal
Mean55.1 ± 10.2955.2 ± 10.155.2 ± 10.19
Sex: Female, Male
Sex: Female, Male(Participants)NKTR-102Physician's Treatment of ChoiceTotal
Female429423852
Male000
Region of Enrollment
Region of Enrollment(participants)NKTR-102Physician's Treatment of ChoiceTotal
Canada91524
South Korea434285
Netherlands112
Belgium533992
United States198180378
Italy101222
United Kingdom192342
France364783
Germany044
Spain465197
Russia14923
08

Study locations

153 sites
  • Arizona Oncology Associates, PC - NAHOA
    Flagstaff, Arizona 86001, United States
  • Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center
    Burbank, California 91505, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists
    Oxnard, California 93030, United States
  • Wilshire Oncology Medical Group, Inc.
    Pasadena, California 91105, United States
  • Desert Hematology Oncology Medical Group
    Rancho Mirage, California 92270, United States
  • University of California San Francisco
    San Francisco, California 94143, United States
  • Stanford University School of Medicine
    Stanford, California 94305, United States
  • Kaiser Permanente
    Vallejo, California 94589, United States
  • Rocky Mountain Cancer Centers
    Denver, Colorado 80220, United States
  • Pre clinical Science Bldg LR3
    Washington, District of Columbia 20007, United States
  • Medstar
    Washington, District of Columbia 20010, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224, United States
  • University of Miami School of Medicine
    Miami, Florida 33136, United States
  • Advanced Medical Specialties
    Miami, Florida 33176, United States
  • Florida Cancer Research Institute
    Plantation, Florida 33324, United States
  • Hematology Oncology Associates of the Treasure Coast
    Port Saint Lucie, Florida 34592, United States
  • Northeast Georgia Cancer Care
    Athens, Georgia 30607, United States
  • Peachtree Hematology Oncology Consultants
    Atlanta, Georgia 30318, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • Central Georgia Cancer Care
    Macon, Georgia 31201, United States
  • Northwest Georgia Oncology Centers, P.C.
    Marietta, Georgia 30060, United States
  • Summit Cancer Care, P.C.
    Savannah, Georgia 31405, United States
  • The University of Chicago Medicine
    Chicago, Illinois 60637, United States
  • Oncology Specialists
    Niles, Illinois 60714, United States
  • Illinois Cancer Care, P.C.
    Peoria, Illinois 61547, United States
  • IU Health Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • Hall-Perrine Cancer Center, 3rd Floor
    Cedar Rapids, Iowa 52403, United States
  • Kansas City Cancer Center
    Overland Park, Kansas 66210, United States
  • Louisville Oncology Clinical Research Program
    Louisville, Kentucky 40207, United States
  • Maryland Oncology Hematology, P.A.
    Columbia, Maryland 21044, United States
  • Minnesota Oncology Hematology, P.A.
    Minneapolis, Minnesota 55404, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Coborn Cancer Center
    Saint Cloud, Minnesota 56303, United States
  • Missouri Cancer Associates
    Columbia, Missouri 65201, United States
  • Washington University in St. Louis
    Saint Louis, Missouri 63110, United States
  • Missouri Baptist Medical Center
    Saint Louis, Missouri 63131, United States
  • Frontier Cancer Center and Blood Institute
    Billings, Montana 59102, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Hematology-Oncology Associates of Northern NJ, PA
    Morristown, New Jersey 07962, United States
  • The cancer Institute of New Jersey
    New Brunswick, New Jersey 08901, United States
  • Cooper University Hospital
    Voorhees, New Jersey 08043, United States
  • UNM Cancer Center
    Albuquerque, New Mexico 87106, United States
  • New York Oncology Hematology, P.C.
    Albany, New York 12206, United States
  • Monte fiore
    Bronx, New York 10461, United States
  • Sciode Medical Associates, PLLC, d.b.a. Eastchester Center for Cancer Care
    Bronx, New York 10469, United States
  • Beth Israel Medical Center
    New York, New York 10003, United States
  • Cornell University
    New York, New York 10065, United States
  • SUNY Upstate Medical University
    Syracuse, New York 13210, United States
  • Carolinas Hematology Oncology Associates
    Charlotte, North Carolina 28202, United States
  • DUMC, Duke South
    Durham, North Carolina 27710, United States
  • Sanford Research/USD
    Fargo, North Dakota 58122, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267-0502, United States
  • Comprehensive Breast Cancer
    Columbus, Ohio 43212, United States
  • Signal Point Clinical Research Center
    Middletown, Ohio 45042, United States
  • Northwest Cancer Specialists, P.C.
    Portland, Oregon 97225, United States
  • Medical Oncology Associates of Wyoming Valley, PC
    Kingston, Pennsylvania 18704, United States
  • Cancer Centers of the Carolinas
    Easley, South Carolina 29640, United States
  • Sanford Research/USD
    Sioux Falls, South Dakota 57104, United States
  • The West Clinic
    Memphis, Tennessee 38120, United States
  • Sarah Cannon Research Institute (SCRI)
    Nashville, Tennessee 37203, United States
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • Texas Oncology-Abilene
    Abilene, Texas 79606, United States
  • Texas Oncology-Austin Midtown
    Austin, Texas 78705, United States
  • Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
    Beaumont, Texas 77702, United States
  • Texas Oncology-Bedford
    Bedford, Texas 76022, United States
  • Texas Oncology-Medical City Dallas
    Dallas, Texas 75230, United States
  • Texas Oncology-Dallas Presbyterian Hospital
    Dallas, Texas 75231, United States
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    Dallas, Texas 75246, United States
  • Texas Oncology-Denton South
    Denton, Texas 76210, United States
  • Texas Oncology-Fort Worth
    Fort Worth, Texas 76104, United States
  • Texas Oncology-Memorial City
    Houston, Texas 77024, United States
  • Texas Oncology-Lewisville
    Lewisville, Texas 75067, United States
  • Texas Oncology-Mesquite
    Mesquite, Texas 75150, United States
  • Texas Oncology-Midland Allison Cancer Center
    Midland, Texas 79701, United States
  • Texas Oncology, P.A. - Plano
    Plano, Texas 92270, United States
  • Cancer Care Centers of South Texas
    San Antonio, Texas 78217, United States
  • Texas Oncology - Sherman
    Sherman, Texas 75090, United States
  • Texas Oncology-Tyler
    Tyler, Texas 75702, United States
  • University of Virginia
    Charlottesville, Virginia 22908, United States
  • Virginia Oncology Associates
    Norfolk, Virginia 23502, United States
  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
    Salem, Virginia 24153, United States
  • Virginia Mason Medical Center
    Seattle, Washington 98101, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • Cancer Care Northwest
    Spokane, Washington 99202, United States
  • Yakima Valley Memorial Hospital/North Star Lodge
    Yakima, Washington 98902, United States
  • Cancer TEAM Bellin Health
    Green Bay, Wisconsin 54313, United States
  • Institut Jules Bordet
    Bruxelles, 2-2-541-72-26, Belgium
  • GHdC - Site Notre Dame
    Charleroi, 6000, Belgium
  • Universtair Ziekenhuis Antwerpen
    Edegem, 2650, Belgium
  • UZ Gent Medische Oncologie
    Gent, 9000, Belgium
  • UZ Leuven, Campus Gasthuisberg, trialbureau Algemene Medische Oncologie
    Leuven, 3000, Belgium
  • Centre Hospitalier Universitaire de Liège- Site du Sart Tilman
    Liège, 4000, Belgium
  • Centre Hospitalier Universitaire Ambroise Paré
    Mons,, 7000, Belgium
  • GZA Ziekenhuizen, Campus St Augustinus, CLINICAL TRIALS ONCOLOGY
    Wilrijk, 2610, Belgium
  • British Columbia Cancer Agency
    Vancouver, British Columbia V5Z 4E6, Canada
  • Odette Cancer Centre OCC Clinical Research
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
  • CHUM-Hopital Notre-Dame
    Montreal, Quebec H2L 4M1, Canada

Showing the first 100 of 153 sites across 11 countries.

09

References and documents

Publications

  • Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. PubMed 30957581 ↗
  • Cortes J, Rugo HS, Awada A, Twelves C, Perez EA, Im SA, Gomez-Pardo P, Schwartzberg LS, Dieras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, O'Shaughnessy J. Prolonged survival in patients with breast cancer and a history of brain metastases: results of a preplanned subgroup analysis from the randomized phase III BEACON trial. Breast Cancer Res Treat. 2017 Sep;165(2):329-341. doi: 10.1007/s10549-017-4304-7. Epub 2017 Jun 13. Erratum In: Breast Cancer Res Treat. 2017 Nov;166(1):327-328. doi: 10.1007/s10549-017-4482-3. PubMed 28612225 ↗
  • Twelves C, Cortes J, O'Shaughnessy J, Awada A, Perez EA, Im SA, Gomez-Pardo P, Schwartzberg LS, Dieras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Rugo HS. Health-related quality of life in patients with locally recurrent or metastatic breast cancer treated with etirinotecan pegol versus treatment of physician's choice: Results from the randomised phase III BEACON trial. Eur J Cancer. 2017 May;76:205-215. doi: 10.1016/j.ejca.2017.02.011. Epub 2017 Mar 27. PubMed 28360015 ↗
  • Perez EA, Awada A, O'Shaughnessy J, Rugo HS, Twelves C, Im SA, Gomez-Pardo P, Schwartzberg LS, Dieras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Cortes J. Etirinotecan pegol (NKTR-102) versus treatment of physician's choice in women with advanced breast cancer previously treated with an anthracycline, a taxane, and capecitabine (BEACON): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1556-1568. doi: 10.1016/S1470-2045(15)00332-0. Epub 2015 Oct 22. PubMed 26482278 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01492101
Lead sponsor
Nektar Therapeutics
Responsible party
Sponsor
First posted
Dec 14, 2011
Start date
Dec 2011
Primary completion
Apr 2016
Completion
Jun 2016
Results posted
Jun 1, 2021
Last update
Jun 1, 2021

Study contacts

Alison Hannah, MD
study director · Nektar Therapeutics

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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