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

Phase 1

• Conditions: Adrenocortical Carcinoma; MedDRA version: 12.0Level: LLTClassification code 10001388Term: Adrenocortical carcinoma; MedDRA version: 12.0Level: PTClassification code 10001388Term: Adrenocortical carcinoma

• Registration Number: EUCTR2009-012820-97-NL
• Lead Sponsor: OSI Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-20
• Study Completion: 2012-07-11
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

•Histologically confirmed adrenocortical carcinoma;
•Measurable disease according to RECIST (version 1.1);
•ECOG PS •Fasting glucose –Concurrent use of non-insulinotropic oral antihyperglycemic therapy is permitted if the dose has been stable for >/= 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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy;
•Prior IGF-1R inhibitor therapy;
•History of significant cardiovascular disease unless the disease is well controlled. Significant disease includes second/third degree heart block; clinically significant ischemic heart disease; QTcF interval > 450 msec at screening; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse; and/or
•Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objectives of this study are to evaluate:<br>•progression-free survival, disease control rate, best overall response rate, and duration of response;<br>•quality of life (as measured by EORTC QLQ-C30;<br>•the safety profile of OSI-906; <br>•the pharmacokinetic profile of OSI-906; and<br>•pharmacodynamic changes and correlations with treatment outcome.<br>;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).;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.