A Phase 2 interventional study of Pazopanib in Advanced Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, sponsored by Novartis Pharmaceuticals. Completed at 22 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
The main purpose of this study was to assess the progression-free survival (PFS) based on local investigator assessment of pazopanib in participants with advanced and/or metastatic renal cell carcinoma (mRCC) following prior treatment with immune checkpoint inhibitors (ICI).
This was a multi-center, open-label, single-arm Phase II study to determine the efficacy, tolerability, safety and quality of life of treatment with pazopanib in subjects with advanced and/or metastatic renal cell carcinoma (RCC) following prior treatment with immune checkpoint inhibitors (ICI).
Subjects could have received prior systemic therapy with an ICI (monotherapy or combination) as 1st or 2nd line RCC treatment. However, they must not have received pazopanib previously. In this study, pazopanib could be administered in the 2nd or 3rd line setting. The therapeutic line for individual subjects was assigned at the time of screening.
Subjects received 800 mg of pazopanib daily until disease progression, unacceptable toxicity, death, pregnancy, start of a new anti-neoplastic therapy, discontinuation at the discretion of the investigator or patient, lost to follow-up or end of study, whichever came first.
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This study's enrollment of 62 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Participants received pazopanib as 2nd line treatment
Drug: Pazopanib
Participants received pazopanib as 3rd line treatment
Drug: Pazopanib
Participants received 800mg of pazopanib once daily orally. Pazopanib was supplied as aqueous film-coated tablets containing 200 mg or 400 mg.
Progression Free Survival (PFS)
PFS is defined as the time from the start date of pazopanib treatment to the date of the first documented progression or death due to any cause. PFS was assessed via local review according to RECIST 1.1. PFS was censored at the date of the last adequate tumor assessment if no PFS event (disease progression or death due to any cause) was observed prior to the analysis cut-off date. The PFS distribution was estimated using the Kaplan-Meier method.
Time frame: Date of first treatment to date of progression or death up to approximately 38 months
Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1
ORR is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: Up to approximately 38 months
Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1.
CBR is defined as the percentage of participants with a best overall response of CR or PR or an overall lesion response of stable disease (SD) or Non-CR/Non-PD lasting ≥ 24 weeks based on local investigator's assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Time frame: Up to approximately 38 months
Overall Survival (OS)
OS is defined as the time from the first administration of study treatment until death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date patient alive. The OS distribution was estimated using the Kaplan-Meier method.
Time frame: From date of first treatment to date of death, up to approximately 44 months
Duration of Response (DOR) Based on Local Investigators Assessment According to RECIST v1.1
DOR is defined as the time from the date of first documented response (confirmed CR or PR according to RECIST v1.1 based on local Investigators review of tumor assessment data) to the date of tumor progression, or death due to underlying cancer, whichever comes first. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. The DOR distribution was calculated using the Kaplan-Meier method.
Time frame: From the date of first documented response (confirmed CR or PR) to the date of tumor progression, up to approximately 36 months
Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score
FKSI-DRS is a 9-item questionnaire specifically designed to evaluate symptoms that are directly attributable to kidney cancer and includes patient's symptoms in the past seven days such as lack of energy, pain, bone-pain, shortness of breath, fatigue, blood in urine, etc. Each item is scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (no symptoms) to 36 (most severe symptoms) with a higher score indicating greater presence of kidney cancer symptoms. The baseline is defined as the last FKSI-DRS assessment on or prior to first day of treatment. A negative change from baseline indicates improvement in kidney cancer symptom status.
Time frame: Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days
Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ-5L-5D VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating higher health-related quality of life. The baseline is defined as the last EQ-5L-5D assessment on or prior to first day of treatment. A positive change from baseline indicates improvement in the heath state.
Time frame: Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days
The study was conducted across 22 centers in 11 countries
| Milestone | Pazopanib- 2nd Line | Pazopanib- 3rd Line |
|---|---|---|
| Started | 47 | 15 |
| Completed | 6 | 0 |
| Not completed | 41 | 15 |
| Withdrew: Progressive disease | 24 | 5 |
| Withdrew: Adverse event | 11 | 8 |
| Withdrew: Physician decision | 3 | 2 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Subject/guardian decision | 1 | 0 |
PFS is defined as the time from the start date of pazopanib treatment to the date of the first documented progression or death due to any cause. PFS was assessed via local review according to RECIST 1.1. PFS was censored at the date of the last adequate tumor assessment if no PFS event (disease progression or death due to any cause) was observed prior to the analysis cut-off date. The PFS distribution was estimated using the Kaplan-Meier method.
| Months | Pazopanib- 2nd Line | Pazopanib- 3rd Line | All Participants |
|---|---|---|---|
| Progression Free Survival (PFS) | 7.5 (3.7 to 12.6) | 4.6 (3.3 to 9.2) | 6.8 (3.7 to 11.1) |
ORR is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| Percentage of participants | Pazopanib- 2nd Line | Pazopanib- 3rd Line | All Participants |
|---|---|---|---|
| Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1 | 23.4 (12.3 to 38.0) | 0 (0.0 to 21.8) | 17.7 (9.2 to 29.5) |
CBR is defined as the percentage of participants with a best overall response of CR or PR or an overall lesion response of stable disease (SD) or Non-CR/Non-PD lasting ≥ 24 weeks based on local investigator's assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
| Percentage of participants | Pazopanib- 2nd Line | Pazopanib- 3rd Line | All Participants |
|---|---|---|---|
| Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1. | 53.2 (38.1 to 67.9) | 40.0 (16.3 to 67.7) | 50.0 (37.0 to 63.0) |
OS is defined as the time from the first administration of study treatment until death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date patient alive. The OS distribution was estimated using the Kaplan-Meier method.
| Months | Pazopanib- 2nd Line | Pazopanib- 3rd Line | All Participants |
|---|---|---|---|
| Overall Survival (OS) | 27.8 (14.9 to NA) | 20.0 (9.2 to 25.6) | 23.4 (14.9 to 31.8) |
DOR is defined as the time from the date of first documented response (confirmed CR or PR according to RECIST v1.1 based on local Investigators review of tumor assessment data) to the date of tumor progression, or death due to underlying cancer, whichever comes first. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. The DOR distribution was calculated using the Kaplan-Meier method.
| Months | Pazopanib- 2nd Line | Pazopanib- 3rd Line |
|---|---|---|
| Duration of Response (DOR) Based on Local Investigators Assessment According to RECIST v1.1 | NA (9.5 to NA) | — |
FKSI-DRS is a 9-item questionnaire specifically designed to evaluate symptoms that are directly attributable to kidney cancer and includes patient's symptoms in the past seven days such as lack of energy, pain, bone-pain, shortness of breath, fatigue, blood in urine, etc. Each item is scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (no symptoms) to 36 (most severe symptoms) with a higher score indicating greater presence of kidney cancer symptoms. The baseline is defined as the last FKSI-DRS assessment on or prior to first day of treatment. A negative change from baseline indicates improvement in kidney cancer symptom status.
| Score on a scale | Pazopanib- 2nd Line | Pazopanib- 3rd Line | All Participants |
|---|---|---|---|
| Cycle 2 Day 1 | -1.3 ± 4.95 | -0.3 ± 4.31 | -1.0 ± 4.78 |
| Cycle 3 Day 1 | -0.5 ± 4.55 | 1.7 ± 4.18 | -0.0 ± 4.51 |
| Cycle 4 Day 1 | -0.1 ± 2.97 | 1.8 ± 4.22 | 0.2 ± 3.24 |
| Cycle 5 Day 1 | 0.1 ± 3.13 | 2.0 ± 2.35 | 0.4 ± 3.06 |
| Cycle 6 Day 1 | -0.3 ± 5.68 | 2.7 ± 3.27 | 0.3 ± 5.36 |
| Cycle 7 Day 1 | -0.1 ± 3.47 | 2.5 ± 3.73 | 0.4 ± 3.63 |
| Cycle 9 Day 1 | -0.1 ± 4.22 | — | -0.1 ± 4.22 |
| Cycle 11 Day 1 | 0.7 ± 3.30 | 0.0 ± NA | 0.6 ± 3.20 |
| Cycle 13 Day 1 | 1.4 ± 2.12 | — | 1.4 ± 2.12 |
| Cycle 16 Day 1 | 0.6 ± 1.59 | — | 0.6 ± 1.59 |
| Cycle 19 Day 1 | 0.0 ± 2.76 | — | 0.0 ± 2.76 |
| Cycle 22 Day 1 | -0.5 ± 3.27 | — | -0.5 ± 3.27 |
| Cycle 25 Day 1 | 2.0 ± 2.31 | — | 2.0 ± 2.31 |
| Cycle 31 Day 1 | 0.5 ± 0.71 | — | 0.5 ± 0.71 |
| Cycle 34 Day 1 | 1.0 ± NA | — | 1.0 ± NA |
| Cycle 37 Day 1 | 1.0 ± NA | — | 1 ± NA |
| End of Treatment | -0.6 ± 3.86 | -0.8 ± 6.00 | -0.6 ± 4.37 |
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ-5L-5D VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating higher health-related quality of life. The baseline is defined as the last EQ-5L-5D assessment on or prior to first day of treatment. A positive change from baseline indicates improvement in the heath state.
| Score on a scale | Pazopanib- 2nd Line | Pazopanib- 3rd Line | All Participants |
|---|---|---|---|
| Cycle 2 Day 1 | 0.1 ± 16.44 | -1.9 ± 19.46 | -0.4 ± 17.02 |
| Cycle 3 Day 1 | -2.8 ± 14.35 | 3.6 ± 19.28 | -1.3 ± 15.58 |
| Cycle 4 Day 1 | -0.7 ± 10.88 | -1.5 ± 22.86 | -0.8 ± 13.27 |
| Cycle 5 Day 1 | -1.5 ± 13.61 | 3.2 ± 19.51 | -0.7 ± 14.45 |
| Cycle 6 Day 1 | -1.3 ± 18.35 | -3.5 ± 24.09 | -1.7 ± 19.21 |
| Cycle 7 Day 1 | 0.2 ± 11.89 | 0.7 ± 20.37 | 0.3 ± 13.73 |
| Cycle 9 Day 1 | 3.8 ± 11.64 | — | 3.8 ± 11.64 |
| Cycle 11 Day 1 | 3.9 ± 12.62 | -2.0 ± NA | 3.5 ± 12.30 |
| Cycle 13 Day 1 | 5.7 ± 12.26 | — | 5.7 ± 12.26 |
| Cycle 16 Day 1 | -1.3 ± 11.70 | — | -1.3 ± 11.70 |
| Cycle 19 Day 1 | 5.5 ± 10.09 | — | 5.5 ± 10.09 |
| Cycle 22 Day 1 | 0.5 ± 9.93 | — | 0.5 ± 9.93 |
| Cycle 25 Day 1 | 0.0 ± 9.70 | — | 0.0 ± 9.70 |
| Cycle 31 Day 1 | 99.5 ± 0.71 | — | 99.5 ± 0.71 |
| Cycle 34 Day 1 | 10.0 ± NA | — | 10.0 ± NA |
| Cycle 37 Day 1 | 90.0 ± NA | — | 90.0 ± NA |
| End of Treatment | -1.9 ± 20.84 | -8.9 ± 19.99 | -3.6 ± 20.59 |
On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication, for a maximum duration of approximately 38 months. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study medication to end of study, up to approximately 44 months. All deaths refer to the sum of on-treatment deaths and post-treatment survival follow-up deaths.
| Participants | Pazopanib- 2nd Line | Pazopanib- 3rd Line | All Participants |
|---|---|---|---|
| On-treatment deaths | 5 | 1 | 6 |
| Post-treatment survival follow-up deaths | 22 | 10 | 32 |
| All deaths | 27 | 11 | 38 |
Collected over Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 44 months. These are not considered Adverse Events. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pazopanib- 2nd Line (On-Treatment) | 5/47 (10.6%) | 21/47 (44.7%) | 46/47 (97.9%) |
| Pazopanib- 3rd Line (On-Treatment) | 1/15 (6.7%) | 9/15 (60%) | 14/15 (93.3%) |
| Pazopanib- 2nd Line (Post-treatment Survival Follow-up) | 22/35 (62.9%) | — | — |
| Pazopanib- 3rd Line (Post-treatment Survival Follow-up) | 10/13 (76.9%) | — | — |
| Event | Pazopanib- 2nd Line (On-Treatment) | Pazopanib- 3rd Line (On-Treatment) | Pazopanib- 2nd Line (Post-treatment Survival Follow-up) | Pazopanib- 3rd Line (Post-treatment Survival Follow-up) |
|---|---|---|---|---|
| Alanine aminotransferase increasedInvestigations | 2/47 | 3/15 | — | — |
| AnaemiaBlood and lymphatic system disorders | 0/47 | 1/15 | — | — |
| Abdominal pain upperGastrointestinal disorders | 0/47 | 1/15 | — | — |
| AscitesGastrointestinal disorders | 0/47 | 1/15 | — | — |
| VomitingGastrointestinal disorders | 0/47 | 1/15 | — | — |
| Drug-induced liver injuryHepatobiliary disorders | 0/47 | 1/15 | — | — |
| Immune system disorderImmune system disorders | 0/47 | 1/15 | — | — |
| Bronchitis viralInfections and infestations | 0/47 | 1/15 | — | — |
| Urinary tract infectionInfections and infestations | 1/47 | 1/15 | — | — |
| Transaminases increasedInvestigations | 1/47 | 1/15 | — | — |
| Event | Pazopanib- 2nd Line (On-Treatment) | Pazopanib- 3rd Line (On-Treatment) | Pazopanib- 2nd Line (Post-treatment Survival Follow-up) | Pazopanib- 3rd Line (Post-treatment Survival Follow-up) |
|---|---|---|---|---|
| FatigueGeneral disorders | 15/47 | 8/15 | — | — |
| DiarrhoeaGastrointestinal disorders | 24/47 | 6/15 | — | — |
| Alanine aminotransferase increasedInvestigations | 7/47 | 5/15 | — | — |
| DysgeusiaNervous system disorders | 5/47 | 5/15 | — | — |
| Decreased appetiteMetabolism and nutrition disorders | 14/47 | 3/15 | — | — |
| HypertensionVascular disorders | 13/47 | 3/15 | — | — |
| NauseaGastrointestinal disorders | 12/47 | 4/15 | — | — |
| Aspartate aminotransferase increasedInvestigations | 5/47 | 4/15 | — | — |
| Blood alkaline phosphatase increasedInvestigations | 2/47 | 4/15 | — | — |
| Blood bilirubin increasedInvestigations | 3/47 | 4/15 | — | — |
| Age, Continuous(Years) | Pazopanib- 2nd Line | Pazopanib- 3rd Line | Total |
|---|---|---|---|
| Mean | 62.4 ± 11.55 | 65.4 ± 9.77 | 63.2 ± 11.15 |
| Sex: Female, Male(Participants) | Pazopanib- 2nd Line | Pazopanib- 3rd Line | Total |
|---|---|---|---|
| Female | 11 | 4 | 15 |
| Male | 36 | 11 | 47 |
| Race/Ethnicity, Customized(Participants) | Pazopanib- 2nd Line | Pazopanib- 3rd Line | Total |
|---|---|---|---|
| White | 44 | 13 | 57 |
| Asian | 1 | 0 | 1 |
| Other | 0 | 1 | 1 |
| Unknown | 2 | 1 | 3 |
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