Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
NCT01835158 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157
Last updated 2021-02-11
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
- Clear Cell Renal Cell Carcinoma
- Metastatic Kidney Carcinoma
- Stage III Renal Cell Cancer AJCC v7
- Stage IV Renal Cell Cancer AJCC v7
Interventions
- DRUG
-
Cabozantinib S-malate
Given PO
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Sunitinib Malate
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Toni K Choueiri · Alliance for Clinical Trials in Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-08
- Primary Completion
- 2016-04-18
Countries
- United States
Study Locations
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