NCT01101906

A Randomized, Placebo-controlled, Double-blind Phase 2 Study With OSI-906 in Patients With Advanced HCC

A Randomized, Placebo-controlled, Double-blinded Phase 2 Study of Second-line Treatment With OSI-906 in Patients With Advanced Hepatocellular Carcinoma (HCC) After Failure of First-line Treatment With Sorafenib

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled, double-blind phase 2 study of OSI-906 or placebo at a continuous 150 mg twice daily (BID) dose.

Detailed description

Adult patients with advanced HCC previously treated with sorafenib will be randomized 2:1 to receive either single agent OSI-906 or placebo

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	OSI-906	OSI-906 administered orally
DRUG	Placebo	Matching placebo administered orally

Timeline

• Start date: 2011-01-10
• Primary completion: 2011-11-04
• Completion: 2011-12-28
• First posted: 2010-04-12
• Last updated: 2024-11-20

Locations

41 sites across 10 countries: United States, Belgium, France, Germany, Hong Kong, Italy, Singapore, South Korea, Spain, Taiwan