~16 spots leftby Apr 2026

Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

Recruiting in Palo Alto (17 mi)
+118 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Pfizer
No Placebo Group
Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment. The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Inclusion Criteria

Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
Measurable disease

Treatment Details

Interventions

  • Sunitinib Malate Continuous Daily Dosing (Tyrosine Kinase Inhibitor)
  • Sunitinib Malate Schedule 4/2 (Tyrosine Kinase Inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: CExperimental Treatment1 Intervention
Group II: AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University