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

Recruiting in Palo Alto (17 mi)

+487 other locations

Overseen byToni K Choueiri

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Renal cell carcinoma with some component of clear cell histology; histologic documentation of metastatic disease is not required

Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma (RCC) (equivalent to stage IV RCC, according to American Joint Committee on Cancer [AJCC] staging)

Time from diagnosis of RCC to systemic treatment < 1 year

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Treatment Details

Interventions

Cabozantinib S-malate (Tyrosine Kinase Inhibitor)
Sunitinib Malate (Tyrosine Kinase Inhibitor)

Participant Groups

2Treatment groups

Active Control

Group I: Arm I (cabozantinib-s-malate)Active Control2 Interventions

Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (sunitinib malate)Active Control2 Interventions

Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cabozantinib S-malate is already approved in United States, United States, European Union for the following indications:

🇺🇸 Approved in United States as Cabometyx for: