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

INTERVENTION: Product Name: OSI‐906 Pharmaceutical Form: Tablet CAS Number: 867160‐71‐2 Current Sponsor code: OSI‐906 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: OSI‐906 Pharmaceutical Form: Tablet CAS Number: 867160‐71‐2 Current Sponsor code: OSI‐906 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: OSI‐906 Pharmaceutical Form: Tablet CAS Number: 867160‐71‐2 Current Sponsor code: OSI‐906 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Adrenocortical Carcinoma ; MedDRA version: 12.0 Level: LLT Classification code 10001388 Term: Adrenocortical carcinoma ; MedDRA version: 12.0 Level: PT Classification code 10001388 Term: Adrenocortical carcinoma PRIMARY OUTCOME: Main Objective: The primary objective of this study is to determine the overall survival (OS) of single agent OSI‐906 (Arm A) versus placebo (Arm B) in patients with adrenocortical carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens. Primary end point(s): The primary efficacy variable is overall survival. The secondary efficacy variables include progression‐free survival, disease control rate, best objective response reate, duration of response and time to deterioration in quality of life (as measured by EORTC QLQ‐C30). Secondary Objective: The secondary objectives of this study are to evaluate:; • progression‐free survival, disease control rate, best overall response rate, and duration of response;; • quality of life (as measured by EORTC QLQ‐C30;; • the safety profile of OSI‐906; ; • the pharmacokinetic profile of OSI‐906; and; • pharmacodynamic changes and correlations with treatment outcome.; INCLUSION CRITERIA: • Histologically confirmed adrenocortical carcinoma; • Measurable disease according to RECIST (version 1.1); • ECOG PS /= 4 weeks at the time of randomization. • At least 1 but no more than 2 prior drug regimens for locally advanced/metastatic ACC. A minimum of 3 weeks must have elapsed between the end of prior treatment and randomization: – All patients must have received prior mitotane, either as neoadjuvant, adjuvant, or locally advanced/metastatic therapy. – Adjuvant and neoadjuvant mitotane will not be counted as prior drug regimens or systemic cytotoxic chemotherapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years)