Cabozantinib vs Sunitinib for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Matthew T Campbell | MD Anderson Cancer ...

Overseen byMatthew Campbell, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The goal of this clinical research study is to compare the safety and effectiveness of cabozantinib and sunitinib when given to patients with metastatic (has spread) variant histology renal cell carcinoma (vhRCC), a type of kidney cancer. This is an investigational study. Cabozantinib and sunitinib are both FDA approved and commercially available for the treatment of advanced kidney cancer, including vhRCC. The study doctor can explain how the study drugs are designed to work. Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria

This trial is for adults with a specific type of kidney cancer that has spread and may have had one prior treatment excluding certain drugs. They should be in good physical condition, not pregnant, able to follow the study plan, and willing to use contraception. People with certain medical conditions or who've taken specific treatments recently can't join.

Inclusion Criteria

I understand the study requirements and have signed the consent form.

You have had a recent assessment of all known disease sites using scans like CT, MRI, or bone scan within the last 28 days before starting the medication.

Before starting the medication, your blood and organ function need to be within certain levels. For example, your white blood cell count needs to be at least 2500/mm^3, and your bilirubin levels need to be below a certain number.

+7 more

Exclusion Criteria

My kidney cancer is a specific type without any clear cell components.

I am on certain blood thinners or platelet inhibitors, but not for brain metastases.

I have fully healed from any major surgery 1 month before starting the treatment and have no ongoing complications.

+14 more

Participant Groups

The trial aims to compare the safety and effectiveness of two FDA-approved drugs for advanced kidney cancer: cabozantinib and sunitinib malate. Participants will receive either drug to determine which works better against this particular form of cancer.

2Treatment groups

Experimental Treatment

Group I: Group 2 (sunitinib malate)Experimental Treatment1 Intervention

Participants receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Group 1 (cabozantinib)Experimental Treatment1 Intervention

Participants receive cabozantinib PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Cabometyx for: