NCT00247676

An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer

An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg \[milligrams\] with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival

Conditions

• Liver Neoplasms
• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sunitinib (SU011248)	Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-02-01
• Completion: 2009-02-01
• First posted: 2005-11-02
• Last updated: 2010-02-18
• Results posted: 2010-02-02

Locations

8 sites across 3 countries: France, South Korea, Taiwan