Status:
TERMINATED
Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
This study was terminated on April 22th, 2010, based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that sunitinib did not meet the cr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
1075 Patients enrolled
Trial Details
Trial ID
NCT00699374
Start Date
July 1 2008
End Date
December 1 2011
Last Update
January 14 2013
Active Locations (171)
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1
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
2
Pfizer Investigational Site
La Jolla, California, United States, 92037
3
Pfizer Investigational Site
La Jolla, California, United States, 92093
4
Pfizer Investigational Site
Orange, California, United States, 92868