Trial · NCT01835158
Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
NCT01835158, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2018-12-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer. Trials, record NCT01835158. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01835158
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
- NCT number
- NCT01835158
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 157 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Clear Cell Renal Cell Carcinoma, Metastatic Kidney Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7
- Interventions
- Cabozantinib S-malate, Laboratory Biomarker Analysis, Sunitinib Malate
- First posted
- 2013-04-18
- Last updated
- 2021-02-11
- Results first posted
- 2018-12-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Up to 5 years | Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published |
| Primary | Overall Survival (OS) | Up to 5 years | The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on OS. The Kaplan-Meier product-limit estimator will be used to estimate OS distributions. |
| Secondary | Objective Response Rates | Up to 5 years | Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms. |
Source ClinicalTrials.gov
Outcomes3
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) | Up to 5 years | All patients that were enrolled on to study. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to 5 years | All enrolled patients | Months | MEDIAN |
| SECONDARY | Objective Response Rates | Up to 5 years | All enrolled patients. | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
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) | Arm I (Cabozantinib-s-malate) | 8.2 | 95% Confidence Interval 6.2 to 8.8 | Months | |
| Progression Free Survival (PFS) | Arm II (Sunitinib Malate) | 5.6 | 95% Confidence Interval 3.4 to 8.1 | Months | |
| Overall Survival (OS) | Arm I (Cabozantinib-s-malate) | 30.3 | 95% Confidence Interval 14.6 to 35.0 | Months | |
| Overall Survival (OS) | Arm II (Sunitinib Malate) | 21.8 | 95% Confidence Interval 16.3 to 27.0 | Months | |
| Objective Response Rates | Arm I (Cabozantinib-s-malate) | 0.33 | 95% Confidence Interval 0.23 to 0.44 | proportion of participants | |
| Objective Response Rates | Arm II (Sunitinib Malate) | 0.12 | 95% Confidence Interval 0.054 to 0.21 | proportion of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Cabozantinib-s-malate) | 79 | |
| Overall Study | STARTED | Arm II (Sunitinib Malate) | 78 | |
| Overall Study | COMPLETED | Arm I (Cabozantinib-s-malate) | 78 | |
| Overall Study | COMPLETED | Arm II (Sunitinib Malate) | 72 | |
| Overall Study | NOT COMPLETED | Arm I (Cabozantinib-s-malate) | 1 | |
| Overall Study | NOT COMPLETED | Arm II (Sunitinib Malate) | 6 |
Source ClinicalTrials.gov
Adverse events638
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 | Arm I (Cabozantinib-s-malate) | 29 | 78 | 94 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Sunitinib Malate) | 32 | 72 | 103 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Arm I (Cabozantinib-s-malate) | 2 | 78 | 3 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Arm II (Sunitinib Malate) | 1 | 72 | 1 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm I (Cabozantinib-s-malate) | 1 | 78 | 1 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm II (Sunitinib Malate) | 1 | 72 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Arm I (Cabozantinib-s-malate) | 2 | 78 | 7 |
| other | Atrial fibrillation | Cardiac disorders | Arm II (Sunitinib Malate) | 0 | 72 | 0 |
| other | Atrial flutter | Cardiac disorders | Arm I (Cabozantinib-s-malate) | 1 | 78 | 2 |
| other | Atrial flutter | Cardiac disorders | Arm II (Sunitinib Malate) | 0 | 72 | 0 |
1 to 10 of 638Source ClinicalTrials.gov
See all 638 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Cabozantinib-s-malate) | ||
| Total, all-cause mortality | Arm II (Sunitinib Malate) | ||
| Total, other adverse events | Arm I (Cabozantinib-s-malate) | 76 | 78 |
| Total, other adverse events | Arm II (Sunitinib Malate) | 68 | 72 |
| Total, serious adverse events | Arm I (Cabozantinib-s-malate) | 39 | 78 |
| Total, serious adverse events | Arm II (Sunitinib Malate) | 39 | 72 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Cabozantinib-s-malate) vs Arm II (Sunitinib Malate): serious adverse events |
Source Trial comparisons
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/NCT01835158
GET https://conductscience.org/api/trials/v1/NCT01835158/events?page=2