A Clinical Trial Investigating OSI-906 in Patients with Adrenocortical Carcinoma

• Conditions: Adrenocortical Carcinoma; MedDRA version: 14.1Level: PTClassification code 10001388Term: Adrenocortical carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-012820-97-DE
• Lead Sponsor: Astellas Pharma Global Development, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-17
• Last Update Posted: 23 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Histologically confirmed adrenocortical carcinoma;
• Measurable disease according to RECIST (version 1.1);
• ECOG PS <= 2;
• 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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

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