Cabozantinib vs Sunitinib for Kidney Cancer

Palo Alto (17 mi)

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

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.

I am 18 years old or older.

I can take care of myself but might not be able to do heavy physical work.

I agree to use two forms of birth control during the study and for 4 months after.

Exclusion Criteria

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

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

I have previously been treated with drugs that stop the formation of new blood vessels in tumors, including cabozantinib.

I haven't had recent radiation for bone metastasis or other radiation treatments.

I have had brain metastases treated and stable for 4 weeks, and I'm not on steroids.

I do not have serious heart issues, uncontrolled high blood pressure, or recent major cardiovascular events.

I have serious stomach or intestine problems, including recent surgery complications.

I have not had significant bleeding or serious wounds, and my liver and thyroid function are stable.

My heart's electrical activity, measured by QTcF, is not over 500 ms.

I cannot swallow pills.

I need ongoing treatment with certain strong medications.

Treatment Details

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: