A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients with Locally Advanced or Metastatic Adrenocortical Carcinoma
- Conditions
- adrenocortico carcinomakidney cancer10038364
- Registration Number
- NL-OMON36718
- Lead Sponsor
- Astellas Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- Histologically confirmed adrenocortical carcinoma that is locally advanced or metastatic and not amenable to surgical resection.
- Measurable disease according to RECIST (version 1.1).
- Radiologically-confirmed progressive disease within 6 months prior to randomization.
- Age >= 18 years .
- Predicted life expectancy >= 12 weeks.
- At least 1 but no more than 2 prior drug regimens (including molecular targeted therapy, systemic cytotoxic chemotherapy, biologics, and/or vaccines) 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 therapy will not be counted as prior drug regimens or as systemic cytotoxic chemotherapy.
- Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy.
- Prior IGF-1R inhibitor therapy.
- History of prior malignancy, except for resected basal cell or squamous cell carcinoma of the skin, cured in situ cervical carcinoma, cured ductal carcinoma in situ of the breast, or other cancers where the patient has been disease-free for >= 3 years.
- History of significant cardiovascular disease unless the disease is well-controlled.
- History of cerebrovascular accident (CVA) within 6 months prior to randomization or that resulted in ongoing neurologic instability.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the overal survival of OSI-906 (arm A) versus placebo (arm b) in<br /><br>patients with adrenocortical carcinoma who received at least 1 but no more than<br /><br>2 prior drug regimens.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• progression-free survival, disease control rate, best overall response rate,<br /><br>and duration of response;<br /><br>• quality of life<br /><br>• the safety profile of OSI-906;<br /><br>• the pharmacokinetic profile of OSI-906; and<br /><br>• pharmacodynamic changes and correlations with treatment outcome.</p><br>