Pazopanib for Renal Cell Carcinoma

Palo Alto (17 mi)

Overseen byLeonard J Appleman

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing whether pazopanib hydrochloride can help prevent the return of kidney cancer in patients who have had surgery to remove it. The medication aims to stop cancer cell growth and block blood flow to tumors. Patients will take the drug for several months and be monitored frequently. Pazopanib has been approved for treating kidney cancer since 2009.

Eligibility Criteria

This trial is for patients with metastatic kidney cancer who've had surgery to remove all detectable disease. They should be in good physical condition, able to swallow pills without gastrointestinal issues, and have no remaining signs of cancer on scans. Women must not be pregnant and participants need effective contraception.

Inclusion Criteria

My heart's electrical activity, measured by ECG, is within a safe range.

My kidney cancer is confirmed and has spread, but it's not purely papillary or chromophobe type.

My recent scans show no signs of cancer.

I can swallow pills and don’t have issues absorbing food or medicine.

I am fully active or restricted in physically strenuous activity but can do light work.

I have had surgery to remove kidney cancer.

My initial cancer diagnosis included cancer that had spread to distant parts of my body.

Exclusion Criteria

I have stopped taking any medication that affects my heart's rhythm for a specific period before joining the study.

I have not coughed up more than a half teaspoon of blood in the last 8 weeks.

I am currently taking strong CYP3A4 inhibitors.

Treatment Details

The study compares pazopanib hydrochloride, a drug that may prevent tumor growth by blocking enzymes and blood flow to tumors, against a placebo. It's randomized: patients are put into the treatment or placebo group by chance.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A (Pazopanib)Experimental Treatment4 Interventions

Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the study.

Group II: Arm B (Placebo)Placebo Group4 Interventions

Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the study.