EUCTR2009-012820-97-GB
Active, not recruiting
Phase 1
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients with Locally Advanced or Metastatic Adrenocortical Carcinoma - GALACCTIC
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Astellas Pharma Global Development, Inc.
- Enrollment
- 135
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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