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

Stopped early · Phase 3

Conditions studied: Carcinoma, Hepatocellular

In brief

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.

Key facts

Study ID

NCT00699374

Run by

Pfizer

People needed

1075

Starts

2008-07-01

Expected to finish

2011-12-01

Last updated by the study team

2013-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Smyrna, Tennessee, United States
• Pfizer Investigational Site — Mechanicsville, Virginia, United States
• Pfizer Investigational Site — Midlothian, Virginia, United States
• Pfizer Investigational Site — Richmond, Virginia, United States
• Pfizer Investigational Site — Richmond, Virginia, United States
• Pfizer Investigational Site — Seattle, Washington, United States
• Pfizer Investigational Site — Concord, New South Wales, Australia
• Pfizer Investigational Site — Elizabeth Vale, South Australia, Australia
• Pfizer Investigational Site — Woodville South, South Australia, Australia
• Pfizer Investigational Site — Melbourne, Victoria, Australia
• Pfizer Investigational Site — Parkville, Victoria, Australia
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Ghent, Belgium
• Pfizer Investigational Site — Calgary, Alberta, Canada
• Pfizer Investigational Site — Vancouver, British Columbia, Canada
• Pfizer Investigational Site — Kingston, Ontario, Canada
• Pfizer Investigational Site — Toronto, Ontario, Canada
• Pfizer Investigational Site — Montreal, Quebec, Canada
• Pfizer Investigational Site — Hefei, Anhui, China
• Pfizer Investigational Site — Fuzhou, Fujian, China
• Pfizer Investigational Site — Guangzhou, Guangdong, China
• Pfizer Investigational Site — Guangzhou, Guangdong, China
• Pfizer Investigational Site — Nanning, Guangxi, China
• Pfizer Investigational Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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