Trial · NCT03200717
Study of Efficacy, Safety, and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Prior Checkpoint Inhibitor Treatment
NCT03200717, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2023-03-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Efficacy, Safety, and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Prior Checkpoint Inhibitor Treatment. Trials, record NCT03200717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03200717
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy, Safety, and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Prior Checkpoint Inhibitor Treatment
- NCT number
- NCT03200717
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
- Interventions
- Pazopanib
- First posted
- 2017-06-27
- Last updated
- 2023-08-21
- Other registries' IDs
- eudract:2017-000708-10
- Results first posted
- 2023-03-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Date of first treatment to date of progression or death up to approximately 38 months | 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. |
| Secondary | Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1 | Up to approximately 38 months | 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. |
| Secondary | Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1. | Up to approximately 38 months | 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. |
| Secondary | Overall Survival (OS) | From date of first treatment to date of death, up to approximately 44 months | 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. |
| Secondary | Duration of Response (DOR) Based on Local Investigators Assessment According to RECIST v1.1 | From the date of first documented response (confirmed CR or PR) to the date of tumor progression, up to approximately 36 months | 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. |
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score | 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 | 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. |
| Secondary | Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score | 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 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Date of first treatment to date of progression or death up to approximately 38 months | Full Analysis Set (FAS): all subjects to whom study treatment has been assigned and who received at least one dose of pazopanib. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1 | Up to approximately 38 months | Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1. | Up to approximately 38 months | Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From date of first treatment to date of death, up to approximately 44 months | Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Based on Local Investigators Assessment According to RECIST v1.1 | From the date of first documented response (confirmed CR or PR) to the date of tumor progression, up to approximately 36 months | Participants in the Full Analysis Set (FAS) for whom best overall response is complete response (CR) or partial response (PR) | Months | MEDIAN |
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score | 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 | Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib. Number analyzed indicates participants with data available for analyses at the given timepoint. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score | 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 | Full Analysis Set (FAS): All participants to whom study treatment was assigned and who received at least one dose of pazopanib. Number analyzed indicates participants with data available for analyses at the given timepoint. | Score on a scale | MEAN |
| POST_HOC | All Collected Deaths | On-treatment deaths: Up to approximately 38 months. Post-treatment survival follow-up deaths: Up to approximately 44 months | Participants who received at least one dose of pazopanib | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Pazopanib- 2nd Line | 7.5 | 95% Confidence Interval 3.7 to 12.6 | Months | |
| Progression Free Survival (PFS) | Pazopanib- 3rd Line | 4.6 | 95% Confidence Interval 3.3 to 9.2 | Months | |
| Progression Free Survival (PFS) | All Participants | 6.8 | 95% Confidence Interval 3.7 to 11.1 | Months | |
| Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1 | Pazopanib- 2nd Line | 23.4 | 95% Confidence Interval 12.3 to 38.0 | Percentage of participants | |
| Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1 | Pazopanib- 3rd Line | 0 | 95% Confidence Interval 0.0 to 21.8 | Percentage of participants | |
| Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1 | All Participants | 17.7 | 95% Confidence Interval 9.2 to 29.5 | Percentage of participants | |
| Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1. | Pazopanib- 2nd Line | 53.2 | 95% Confidence Interval 38.1 to 67.9 | Percentage of participants | |
| Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1. | Pazopanib- 3rd Line | 40.0 | 95% Confidence Interval 16.3 to 67.7 | Percentage of participants | |
| Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1. | All Participants | 50.0 | 95% Confidence Interval 37.0 to 63.0 | Percentage of participants | |
| Overall Survival (OS) | Pazopanib- 2nd Line | 27.8 | 95% Confidence Interval 14.9 to NA | Months |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pazopanib- 2nd Line | 47 | |
| Overall Study | STARTED | Pazopanib- 3rd Line | 15 | |
| Overall Study | COMPLETED | Pazopanib- 2nd Line | 6 | |
| Overall Study | COMPLETED | Pazopanib- 3rd Line | 0 | |
| Overall Study | NOT COMPLETED | Pazopanib- 2nd Line | 41 | |
| Overall Study | NOT COMPLETED | Pazopanib- 3rd Line | 15 |
Source ClinicalTrials.gov
Adverse events460
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pazopanib- 2nd Line (On-Treatment) | 3 | 47 | |
| other | Anaemia | Blood and lymphatic system disorders | Pazopanib- 3rd Line (On-Treatment) | 1 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Pazopanib- 2nd Line (Post-treatment Survival Follow-up) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | Pazopanib- 3rd Line (Post-treatment Survival Follow-up) | 0 | ||
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pazopanib- 2nd Line (On-Treatment) | 3 | 47 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pazopanib- 3rd Line (On-Treatment) | 1 | 15 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pazopanib- 2nd Line (Post-treatment Survival Follow-up) | 0 | ||
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pazopanib- 3rd Line (Post-treatment Survival Follow-up) | 0 | ||
| other | Hypothyroidism | Endocrine disorders | Pazopanib- 2nd Line (On-Treatment) | 3 | 47 | |
| other | Hypothyroidism | Endocrine disorders | Pazopanib- 3rd Line (On-Treatment) | 3 | 15 |
1 to 10 of 460Source ClinicalTrials.gov
See all 460 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib- 2nd Line (On-Treatment) | 5 | 47 |
| Total, all-cause mortality | Pazopanib- 3rd Line (On-Treatment) | 1 | 15 |
| Total, all-cause mortality | Pazopanib- 2nd Line (Post-treatment Survival Follow-up) | 22 | 35 |
| Total, all-cause mortality | Pazopanib- 3rd Line (Post-treatment Survival Follow-up) | 10 | 13 |
| Total, other adverse events | Pazopanib- 2nd Line (On-Treatment) | 46 | 47 |
| Total, other adverse events | Pazopanib- 3rd Line (On-Treatment) | 14 | 15 |
| Total, other adverse events | Pazopanib- 2nd Line (Post-treatment Survival Follow-up) | 0 | 0 |
| Total, other adverse events | Pazopanib- 3rd Line (Post-treatment Survival Follow-up) | 0 | 0 |
| Total, serious adverse events | Pazopanib- 2nd Line (On-Treatment) | 21 | 47 |
| Total, serious adverse events | Pazopanib- 3rd Line (On-Treatment) | 9 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03200717
GET https://conductscience.org/api/trials/v1/NCT03200717/results?page=2