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CompletedNCT01199055Updated Jul 7, 2020Results posted

CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

A Phase 1 interventional study of CS-7017 and Carboplatin in Carcinoma, Non-Small-Cell Lung, sponsored by Daiichi Sankyo Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Daiichi Sankyo Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung

Keywords

  • PPAR gamma agonist
  • Tumor
  • Cancer
  • Antineoplastic Agent
  • Respiratory Tract Neoplasms
  • Carboplatin
  • Paclitaxel
  • Neoplasms
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 16 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Daiichi Sankyo Co., Ltd. is the lead sponsor of 72 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) 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
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) non-small cell lung cancer (NSCLC)
  • No prior systemic therapy for NSCLC
  • Male or female ≥ 18 years of age
  • Anticipation of more than 3 months survival
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
  • Adequate organ and bone marrow function

Exclusion criteria

Exclusion Criteria:

  • Anticipation of need for a major surgical procedure or radiation therapy during the study
  • Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
  • History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I congestive heart failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic-obstructive pulmonary disease (COPD) or asthma)
  • Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
  • Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)
  • Subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis B surface antigen (HBs)- or hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)- positive and receiving antiretroviral therapy
  • Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction
  • Diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications
  • Treatment with thiazolidinediones (TZDs) within 4 weeks prior to start of study treatment
  • History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
  • Poorly-controlled blood pressure as judged by the Investigator
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    CS-7017+Carboplatin/Paclitaxel

    Drug: CS-7017 from 0.25 mg twice a day (BID) to 0.50 mg BID for up to 4\~6 cycles (1 cycle: 3 weeks) Drug: Carboplatin IV, Area under the curve (AUC) of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks) Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)

    Drug: CS-7017 · Drug: Carboplatin · Drug: Paclitaxel

Interventions

  • DrugCS-7017

    Drug: CS-7017 from 0.25 mg BID to 0.50 mg BID for up to 4\~6 cycles (1 cycle: 3 weeks)

    Also known as: CS7017

  • DrugCarboplatin

    Drug: Carboplatin IV, AUC of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)

    Also known as: Paraplatin

  • DrugPaclitaxel

    Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)

    Also known as: Taxol

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer

    The area under the concentration versus time curve during dosing interval (AUCtau) and up to the last quantifiable time (AUClast) of geometric means of CS-7017 are reported at selected cycles (C) and days (D).

    Time frame: Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose

  2. Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer

    The maximum serum concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).

    Time frame: Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose

  3. Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer

    The time of maximum plasma concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).

    Time frame: Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose

  4. Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer

    Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug.

    Time frame: Baseline to end of Cycle 1, with each treatment cycle being 3 weeks

Secondary outcomes

  1. Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)

    The best overall response is the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], stable disease \[SD\], and progressive disease \[PD\]) among all overall responses from the start of treatment until the participant withdraws from the study. Participants who did not have a tumor assessment, the best overall response is Not Evaluable (NE). The response rate was defined as the proportion of participants with a best overall response of CR or PR, ie, \[confirmed and unconfirmed, (CR + PR) / number of participants\]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions, PR was defined as ≥30% decrease in the sum of diameters of target lesions, PD was defined as ≥20 increase in the smallest sum of diameters, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

    Time frame: Baseline up to Week 18 postdose

  2. CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer

    Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. CS-7017-related TEAEs are those TEAEs that are related to CS-7017 in the relationship.

    Time frame: Baseline to 30 days after last dose, up to approximately 1 year

07

Results

Posted Jul 7, 2020

Participant flow

A total of 18 participants were screened for eligibility. Of the 18 participants who were screened, 16 participants who met all inclusion criteria and no exclusion criteria were enrolled from 17 March 2010 to 15 April 2011 at 1 site in South Korea. All 16 participants received treatment.

Participant flow — Overall Study
MilestoneCS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional Portion
Started349
Completed115
Not completed234
Withdrew: Death010
Withdrew: Physician decision011
Withdrew: Progressive disease212
Withdrew: Withdrawal by subject001

Outcome measures

PrimaryPharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer

The area under the concentration versus time curve during dosing interval (AUCtau) and up to the last quantifiable time (AUClast) of geometric means of CS-7017 are reported at selected cycles (C) and days (D).

Time frame:
Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose
Reported as:
Mean · ng*h/mL
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Geometric Means of Serum Free Form of CS-7017 (R-150033) After Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer
ng*h/mLCS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional Portion
Cycle 1, Week 1: AUCtau70.66 ± 54.11209.33 ± 131.40203.99 ± 91.34
Cycle 1, Week 1: AUClast49.57 ± 36.8687.23 ± 85.6981.54 ± 66.01
Cycle 2, Week 4: AUCtau132.47 ± 25.49345.56 ± 156.29400.89 ± 212.22
Cycle 2, Week 4: AUClast95.94 ± 15.84240.61 ± 107.09268.00 ± 134.40
PrimaryPharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer

The maximum serum concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).

Time frame:
Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose
Reported as:
Mean · ng/mL
Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer
ng/mLCS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional Portion
Cycle 1, Week 1: Cmax8.90 ± 7.0115.98 ± 16.7714.54 ± 9.75
Cycle 2, Week 4: Cmax,ss13.63 ± 1.7733.83 ± 15.4239.58 ± 18.63
PrimaryPharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer

The time of maximum plasma concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).

Time frame:
Initial C1D1, C2D22 and additional C1D3, C2D22 predose, 0.5, 1, 2, 3, 4, 6 and 10h; initial and additional D8 predose; additional D1 predose and 3h; initial and additional D15 predose and 1-3h; C3D43 and C4D64 any time, except additional C3D43 predose
Reported as:
Median · h
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Geometric Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer
hCS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional Portion
Cycle 1, Week 1: Tmax3.90 (1.98 to 3.95)3.00 (2.92 to 6.05)5.95 (2.00 to 8.10)
Cycle 2, Week 4: Tmax,ss3.17 (3.02 to 4.08)3.98 (2.90 to 4.12)3.88 (1.95 to 6.02)
PrimaryTreatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer

Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug.

Time frame:
Baseline to end of Cycle 1, with each treatment cycle being 3 weeks
Reported as:
Count of participants · Participants
Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group During Cycle 1 Following Administration of CS-7017 and Carboplatin/Paclitaxel in Participants With Stage IIIb/IV Non-small Cell Lung Cancer
ParticipantsCS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional Portion
At least one TEAE349
Blood and lymphatic system disorders328
Neutropenia327
Anaemia005
Metabolism and Nutrition Disorders026
Decreased appetite016
Nervous System Disorders114
Neuropathy peripheral014
Respiratory, Thoracic and Mediastinal Disorders104
Pleural effusion004
Gastrointestinal Disorders216
Nausea211
Skin and Subcutaneous Tissue Disorders228
Alopecia218
Pruritus021
Musculoskeletal and Connective Tissue Disorders327
Myalgia206
Athralgia120
General Disorders & Administration Site Conditions315
Fatigue301
Investigations028
Weight increased027
SecondaryBest Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)

The best overall response is the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], stable disease \[SD\], and progressive disease \[PD\]) among all overall responses from the start of treatment until the participant withdraws from the study. Participants who did not have a tumor assessment, the best overall response is Not Evaluable (NE). The response rate was defined as the proportion of participants with a best overall response of CR or PR, ie, \[confirmed and unconfirmed, (CR + PR) / number of participants\]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions, PR was defined as ≥30% decrease in the sum of diameters of target lesions, PD was defined as ≥20 increase in the smallest sum of diameters, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Time frame:
Baseline up to Week 18 postdose
Reported as:
Count of participants · Participants
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)
ParticipantsCS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional PortionCS71017 0.5 mg BID; Initial and Additional PortionOverall
Complete response (CR)00000
Partial response (PR)02466
Stable disease (SD)10223
Progressive disease (PD)21235
Not evaluable (NE)00000
Missing00000
Response rate (CR + PR)02466
SecondaryCS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer

Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug. CS-7017-related TEAEs are those TEAEs that are related to CS-7017 in the relationship.

Time frame:
Baseline to 30 days after last dose, up to approximately 1 year
Reported as:
Count of participants · Participants
CS-7017-Related Treatment-Emergent Adverse Events Occurring in Participants in Any Treatment Group After Administration of CS-7017 and Carboplatin/Paclitaxel in Chemotherapy-naïve Participants With Stage IIIb/IV Non-small Cell Lung Cancer
ParticipantsCS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional Portion
At least one CS-7017-related TEAE238
Respiratory, Thoracic and Mediastinal Disorders014
Pleural effusion014
General Disorders & Administration Site Conditions127
Face oedema124
Oedema peripheral023
Investigations138
Weight increased138

Adverse events

Collected over Treatment-emergent adverse event data were collected from baseline to 30 days after last dose, up to approximately 1 year.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CS-7017 0.25 mg BID; Initial Portion0/3 (0%)2/3 (66.7%)3/3 (100%)
CS-7017 0.50 mg BID; Initial Portion1/4 (25%)1/4 (25%)4/4 (100%)
CS-7017 0.50 mg BID; Additional Portion0/9 (0%)6/9 (66.7%)9/9 (100%)
Most frequent serious events
Most frequent serious events
EventCS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional Portion
Febrile neutropeniaBlood and lymphatic system disorders1/30/42/9
Pericardial effusionCardiac disorders1/30/40/9
Septic shockInfections and infestations0/31/40/9
PyrexiaGeneral disorders0/30/42/9
Pleural effusionRespiratory, thoracic and mediastinal disorders0/30/42/9
Weight increasedInvestigations0/30/41/9
Pneumonia klebsiellaInfections and infestations0/30/41/9
Chest painGeneral disorders0/30/41/9
Back painMusculoskeletal and connective tissue disorders0/30/41/9
Most frequent other events
Showing 10 of 20
Most frequent other events
EventCS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional Portion
NeutropeniaBlood and lymphatic system disorders3/33/49/9
Neuropathy peripheralNervous system disorders3/32/49/9
DizzinessNervous system disorders3/31/42/9
NauseaGastrointestinal disorders3/32/48/9
AlopeciaSkin and subcutaneous tissue disorders2/31/49/9
FatigueGeneral disorders3/31/44/9
AnaemiaBlood and lymphatic system disorders2/33/48/9
Weight increasedInvestigations1/33/48/9
ThrombocytopeniaBlood and lymphatic system disorders2/33/47/9
Decreased appetiteMetabolism and nutrition disorders2/33/47/9

Baseline characteristics

The baseline demographic characteristics were assessed in the Safety Analysis Set.

Age, Categorical
Age, Categorical(Participants)CS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional PortionTotal
<=18 years0000
Between 18 and 65 years22610
>=65 years1236
Age, Continuous
Age, Continuous(years)CS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional PortionTotal
Mean59.7 ± 9.2962.3 ± 5.9158.9 ± 9.9859.9 ± 8.59
Sex: Female, Male
Sex: Female, Male(Participants)CS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional PortionTotal
Female1045
Male24511
Region of Enrollment
Region of Enrollment(participants)CS-7017 0.25 mg BID; Initial PortionCS-7017 0.50 mg BID; Initial PortionCS-7017 0.50 mg BID; Additional PortionTotal
South Korea34916
08

Study locations

1 site
  • Samsung Medical Center
    Seoul, Gangnam-gu 135-710, Korea, Republic of
09

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01199055
Lead sponsor
Daiichi Sankyo Co., Ltd.
Collaborators
ICON Clinical Research
Responsible party
Sponsor
First posted
Sep 10, 2010
Start date
Mar 2010
Primary completion
Apr 2011
Completion
Jul 2011
Results posted
Jul 7, 2020
Last update
Jul 7, 2020

Study contacts

Global Clinical Leader
study director · Daiichi Sankyo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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