Trial · NCT02761057
Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed
NCT02761057, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-09-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed. Trials, record NCT02761057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02761057
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed
- NCT number
- NCT02761057
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 152 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Locally Advanced Papillary Renal Cell Carcinoma, Metastatic Papillary Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7, Type 1 Papillary Renal Cell Carcinoma, Type 2 Papillary Renal Cell Carcinoma, Unresectable Renal Cell Carcinoma
- Interventions
- Biospecimen Collection, Bone Scan, Cabozantinib S-malate, Computed Tomography, Crizotinib, Savolitinib, Sunitinib Malate
- First posted
- 2016-05-04
- Last updated
- 2025-01-13
- Results first posted
- 2022-09-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 3 years | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of appropriate diameters of target lesions over smallest sum observed, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Response Rate (RR) | Up to 3 years | The response rate (RR) is defined as the combined rate of confirmed and unconfirmed partial response and confirmed and unconfirmed complete response. Complete response (CR) is defined as the complete disappearance of all target and non-target lesions, along with no new lesions. Partial response (PR) is defined as \>=30% decrease of the sum of appropriate diameters of all target measurable lesions, along with no new lesions. |
| Secondary | Overall Survival (OS) | Up to 3 years | Duration from date of randomization to date of death from any cause. |
| Secondary | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up until death or 3 years post registration | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Other | MET Mutation Rate | Up to 3 years | The hazard ratio between the MET inhibitor versus (vs.) sunitinib in those with versus without the mutation (i.e., the interaction) will be compared. Response Evaluation Criteria in Solid Tumors (RECIST) response rate (confirmed and unconfirmed partial response and complete response) based on MET mutation/expression level will be compared using the chi-square test. |
Source ClinicalTrials.gov
Outcomes5
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) | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 3 years | Analysis population included eligible participants. | months | MEDIAN |
| SECONDARY | Response Rate (RR) | Up to 3 years | Analysis population included eligible participants. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 3 years | Analysis population included eligible participants. | months | MEDIAN |
| SECONDARY | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up until death or 3 years post registration | Eligible participants who received at least one dose of protocol treatment. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | MET Mutation Rate | Up to 3 years |
Source ClinicalTrials.gov
Results by group276
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) | Sunitinib | 5.6 | 95% Confidence Interval 2.9 to 6.7 | months | |
| Progression Free Survival (PFS) | Cabozantinib | 9.0 | 95% Confidence Interval 5.6 to 12.4 | months | |
| Progression Free Survival (PFS) | Crizotinib | 2.8 | 95% Confidence Interval 2.6 to 3.6 | months | |
| Progression Free Survival (PFS) | Savolitinib | 3.0 | 95% Confidence Interval 2.8 to 7.2 | months | |
| Response Rate (RR) | Sunitinib | 4.35 | percentage of participants | ||
| Response Rate (RR) | Cabozantinib | 22.73 | percentage of participants | ||
| Response Rate (RR) | Crizotinib | 0 | percentage of participants | ||
| Response Rate (RR) | Savolitinib | 3.45 | percentage of participants | ||
| Overall Survival (OS) | Sunitinib | 16.4 | 95% Confidence Interval 12.8 to 21.6 | months | |
| Overall Survival (OS) | Cabozantinib | 20.0 | 95% Confidence Interval 11.3 to NA | months |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Sunitinib Malate) | 48 | |
| Overall Study | STARTED | Arm II (Cabozantinib S-malate) | 46 | |
| Overall Study | STARTED | Arm III (Crizotinib Closed to Accrual 12/5/18) | 28 | |
| Overall Study | STARTED | Arm IV (Savolitinib Closed to Accrual 12/5/18) | 30 | |
| Overall Study | Eligible | Arm I (Sunitinib Malate) | 46 | |
| Overall Study | Eligible | Arm II (Cabozantinib S-malate) | 44 | |
| Overall Study | Eligible | Arm III (Crizotinib Closed to Accrual 12/5/18) | 28 | |
| Overall Study | Eligible | Arm IV (Savolitinib Closed to Accrual 12/5/18) | 29 | |
| Overall Study | Received Protocol Treatment | Arm I (Sunitinib Malate) | 45 | |
| Overall Study | Received Protocol Treatment | Arm II (Cabozantinib S-malate) | 43 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events688
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 | Anemia | Blood and lymphatic system disorders | Sunitinib | 17 | 45 | |
| other | Anemia | Blood and lymphatic system disorders | Cabozantinib | 12 | 43 | |
| other | Anemia | Blood and lymphatic system disorders | Crizotinib | 7 | 27 | |
| other | Anemia | Blood and lymphatic system disorders | Savolitinib | 7 | 28 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Sunitinib | 2 | 45 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Cabozantinib | 5 | 43 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Crizotinib | 0 | 27 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Savolitinib | 1 | 28 | |
| other | Sinus bradycardia | Cardiac disorders | Sunitinib | 2 | 45 | |
| other | Sinus bradycardia | Cardiac disorders | Cabozantinib | 1 | 43 |
1 to 10 of 688Source ClinicalTrials.gov
See all 688 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib | 24 | 46 |
| Total, all-cause mortality | Cabozantinib | 22 | 44 |
| Total, all-cause mortality | Crizotinib | 16 | 28 |
| Total, all-cause mortality | Savolitinib | 21 | 29 |
| Total, other adverse events | Sunitinib | 44 | 45 |
| Total, other adverse events | Cabozantinib | 41 | 43 |
| Total, other adverse events | Crizotinib | 26 | 27 |
| Total, other adverse events | Savolitinib | 27 | 28 |
| Total, serious adverse events | Sunitinib | 15 | 45 |
| Total, serious adverse events | Cabozantinib | 19 | 43 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT02761057
GET https://conductscience.org/api/trials/v1/NCT02761057/results?page=2