Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Niacinamide; Sorafenib; Sunitinib

Criteria

Inclusion Criteria:

• Histologically-confirmed diagnosis of hepatocellular carcinoma

• presence of measurable disease by radiographic imaging

• Child-Pugh class A

• ECOG PS 0 or 1

• adequate organ function.

Exclusion Criteria:

• Prior treatment with any systemic treatment for hepatocellular carcinoma

• prior local treatment within 4 weeks from entry

• presence of clinically relevant ascites

• severe hemorrhage <4 weeks of starting study treatment

• known HIV or serious acute or chronic illness

• current treatment on another clinical trial

• pregnancy or breastfeeding