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Sponsors and Collaborators: |
AOI Pharma, Inc. M.D. Anderson Cancer Center |
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Information provided by: | AOI Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00455559 |
This is a Phase II trial designed to determine the efficacy and safety of perifosine plus imatinib mesylate in patients with advanced GIST who develop progressive disease or recurrence while receiving imatinib mesylate.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Stromal Tumors |
Drug: Perifosine Drug: Imatinib Mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Perifosine Plus Imatinib Mesylate for Patients With Resistant Gastrointestinal Stromal Tumor |
Estimated Enrollment: | 96 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | May 2009 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
This is a Phase II study of perifosine in combination with imatinib mesylate in patients with advanced GIST. Each cycle lasts 28 days. There will be two treatment arms. On both arms, patients will continue the dose of imatinib mesylate taken during the period of disease progression. Patients will be randomized to one either a weekly or a daily perifosine treatment regimen at the time of registration.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
All patients must have progressive disease on imatinib defined as:
Exclusion Criteria
Significant concurrent medical disease other than GIST, including:
Responsible Party: | AOI Pharma, Inc. ( AOI Pharma, Inc. ) |
Study ID Numbers: | Perifosine 210 |
Study First Received: | March 30, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00455559 |
Health Authority: | United States: Food and Drug Administration |
Resistant Gastrointestinal Stromal Tumor GIST Perifosine Gleevec |
Imatinib Digestive System Diseases Digestive System Neoplasms |
Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |