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Sponsors and Collaborators: |
AOI Pharma, Inc. M.D. Anderson Cancer Center |
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 |
MedlinePlus related topics: | Cancer |
Drug Information available for: | Imatinib Imatinib mesylate Perifosine |
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 |
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:
Contact: Online Collaborative Oncology Group | 415-946-2410 | ocogtrials@ocog.net |
United States, Idaho | |||||
AOI Pharmaceuticals Investigative Site | Recruiting | ||||
Couer d'Alene, Idaho, United States, 83814 | |||||
United States, Illinois | |||||
AOI Pharmaceuticals Investigative Site | Recruiting | ||||
Niles, Illinois, United States, 60714 | |||||
United States, Michigan | |||||
AOI Pharmaceuticals Investigative Site | Recruiting | ||||
Grand Rapids, Michigan, United States, 49546 | |||||
United States, Pennsylvania | |||||
AOI Pharmaceuticals Investigative Site | Recruiting | ||||
Sayre, Pennsylvania, United States, 18840 | |||||
United States, Texas | |||||
AOI Pharmaceutical Investigative Site | Recruiting | ||||
Houston, Texas, United States, 77033 |
AOI Pharma, Inc. |
M.D. Anderson Cancer Center |
Study Chair: | Jonathan Trent, MD, PhD | M.D. Anderson Cancer Center |
Study ID Numbers: | Perifosine 210 |
First Received: | March 30, 2007 |
Last Updated: | October 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00455559 |
Health Authority: | United States: Food and Drug Administration |
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