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Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
NCT01835158 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01835158
The ClinicalTrials.gov registry entry for NCT01835158 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01835158 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Colorado, California, Alaska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01835158?
The interventions under investigation include: Cabozantinib S-malate (DRUG), Laboratory Biomarker Analysis (OTHER), Sunitinib Malate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01835158?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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