NCT00924989

A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens

Detailed description

Patients will be randomized 2:1 to receive either single agent OSI-906 (Arm A) or placebo (Arm B) and will be stratified according to prior systemic cytotoxic chemotherapy for ACC, and Eastern Cooperative Oncology Group (ECOG) performance status, and use of \>= 1 oral antihyperglycemic therapy at randomization

Conditions

• Adrenocortical Carcinoma

Interventions

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

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-07-11
• Completion: 2012-10-08
• First posted: 2009-06-19
• Last updated: 2024-11-20

Locations

35 sites across 9 countries: United States, Australia, Canada, France, Germany, Italy, Netherlands, Poland, United Kingdom