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| Sponsor: | OSI Pharmaceuticals |
|---|---|
| Information provided by: | OSI Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00924989 |
Purpose
A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic ACC who received at least 1 but no more than 2 prior drug regimens
| Condition | Intervention | Phase |
|---|---|---|
|
Adrenocortical Carcinoma (ACC) |
Drug: OSI-906 Other: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma |
| Estimated Enrollment: | 135 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Arm A: Single agent OSI-906 administered orally at a dose of 150 mg twice daily
|
Drug: OSI-906
OSI-906 administered orally at a dose of 150 mg twice daily
|
|
2: Placebo Comparator
Arm B: Matching placebo administered orally twice daily
|
Other: Placebo
Matching placebo administered orally twice daily
|
Patients will be randomized 2:1 to receive either single agent OSI-906 (Arm A) or placebo (Arm B) and will be stratified according to prior systemic cytotoxis chemotherapy for ACC, and ECOG performance status, and use of >= 1 oral antihyperglycemic therapy at randomization
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: OSIP Medical Information | 800.572.1932 | medical-information@osip.com |
Show 25 Study Locations| Study Director: | Pilar Nava-Parada, M.D. | OSI Pharmaceuticals |
More Information
| Responsible Party: | OSI Pharmaceuticals ( Dr. Ronit Simantov, Vice President, Clinical Development ) |
| ClinicalTrials.gov Identifier: | NCT00924989 History of Changes |
| Other Study ID Numbers: | OSI-906-301 |
| Study First Received: | June 17, 2009 |
| Last Updated: | August 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
ACCAdrenocortical carcinomaOSI-906IGF-1R |
|
Carcinoma Adrenocortical Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Adrenal Cortex Neoplasms |
Adrenal Gland Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Adrenal Cortex Diseases Adrenal Gland Diseases Endocrine System Diseases |