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NCT01835158 · ClinicalTrials.gov registry record · Phase 2
Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
A Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 157
- Enrollment target
- 20
- Study locations
NCT01835158: Completed Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
NCT01835158 is a Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 157 participants, below the 200-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01835158, a Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v7, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 157 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.
Primary Outcome
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 increas
Conditions Studied
Interventions
- DRUG Cabozantinib S-malate
- OTHER Laboratory Biomarker Analysis
- DRUG Sunitinib Malate
Study Locations (20)
Colorado
- Rocky Mountain Cancer Centers-Aurora - Aurora
- The Medical Center of Aurora - Aurora
- Boulder Community Hospital - Boulder
- Rocky Mountain Cancer Centers-Boulder - Boulder
- Penrose-Saint Francis Healthcare - Colorado Springs
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs
- Porter Adventist Hospital - Denver
- Colorado Blood Cancer Institute - Denver
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Community Cancer Institute - Clovis
- University Oncology Associates - Clovis
- UC San Diego Moores Cancer Center - La Jolla
- San Diego VA Medical Center - San Diego
- UCSF Medical Center-Mount Zion - San Francisco
Alaska
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Alabama
- Southern Cancer Center PC-Providence - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2013-07-08 |
| Phase | Phase 2 |
What the finished NCT01835158 record still lists
NCT01835158 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 200-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (21% lower).
The record links to 4 conditions, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cabozantinib S-malate is the first listed.
NCT01835158 names 20 study sites across 4 states, led by Colorado, California, Alaska.
Frequently Asked Questions
What is clinical trial NCT01835158 about?
NCT01835158 is a clinical study titled "Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer". This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and suniti...
What is the current status of trial NCT01835158?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 157 participants. The study started on 2013-07-08.
What conditions does trial NCT01835158 study?
This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7, Metastatic Kidney Carcinoma, Stage III Renal Cell Cancer AJCC v7.
What interventions are being tested in trial NCT01835158?
The interventions under investigation include: Cabozantinib S-malate (DRUG), Laboratory Biomarker Analysis (OTHER), Sunitinib Malate (DRUG).
Who is sponsoring clinical trial NCT01835158?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01835158 being conducted?
This trial has 20 study locations across Alabama, Alaska, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Clear Cell Renal Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01835158's enrollment target sits among peer trials
157 10th of 45 higher than 36 of 45 other Clear Cell Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clear Cell Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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