Completed
PHASE3
INTERVENTIONAL
NCT00924989
A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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
Interventions
Name:
OSI-906
Type:
DRUG
Description:
Administered orally
Name:
Placebo
Type:
OTHER
Description:
Matching placebo administered orally
Primary Outcomes
Measure:
Overall survival of single agent OSI-906 versus placebo
TimeFrame:
33 months
Description:
Time from date of randomization until time of documented death
Trial Information
NCT ID
NCT00924989
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Astellas Pharma Inc
Last Updated
December 15, 2025