Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib S-malate — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Sunitinib Malate — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Jul 8, 2013

Status verified

Dec 2020

Primary completion

Apr 18, 2016

Study Design

Enrollment

157 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (cabozantinib-s-malate)
  Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm II (sunitinib malate)
  Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]

Locations (488)

Find similar trials in Mobile, AL

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