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

Phase 3 Completed 139 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start: 2009-12-01
Primary completion: 2012-07-11
Completion: 2012-10-08

Outcome

Missed primary endpoint

paper no difference in overall survival was noted between linsitinib and placebo PMID 25795408 ↗

paper hazard ratio 0·94 [95% CI 0·61-1·44]; p=0·77. PMID 25795408 ↗

Publications

Fassnacht M, Berruti A, Baudin E, Demeure MJ, Gilbert J, Haak H, Kroiss M, Quinn DI, Hesseltine E, Ronchi CL, Terzolo M, Choueiri TK, Poondru S, Fleege T, Rorig R, Chen J, Stephens AW, Worden F, Hammer GD. Linsitinib (OSI-906) versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: a double-blind, randomised, phase 3 study. Lancet Oncol. 2015 Apr;16(4):426-35. doi: 10.1016/S1470-2045(15)70081-1. Epub 2015 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	linsitinib	Small molecule	150 mg	Oral