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Sponsors and Collaborators: |
Infinity Pharmaceuticals MedImmune LLC AstraZeneca |
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Information provided by: | Infinity Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00688766 |
IPI-504-06 is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of IPI-504 as compared to placebo in patients with metastatic and/or unresectable GIST following failure of at least imatinib and sunitinib.
Approximately 195 patients will be randomized using a 2:1 ratio to receive either IPI-504 (N=130) or placebo (N=65). Upon unblinding, patients receiving either IPI-504 or placebo may receive IPI-504 in the open-label portion of the study if defined inclusion criteria are met.
Early and frequent imaging timepoints (Weeks 2, 5, 8, 14 and every 6 weeks thereafter) are incorporated into this study to capture progression events and limit patient exposure to ineffective agents.
Condition | Intervention | Phase |
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Gastrointestinal Stromal Tumors |
Drug: retaspimycin hydrochloride (IPI-504) Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of IPI-504 in Patients With Metastatic and/or Unresectable GIST Following Failure of at Least Imatinib and Sunitinib |
Estimated Enrollment: | 195 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
IPI-504 plus best supportive care
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Drug: retaspimycin hydrochloride (IPI-504)
IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90). Patients will receive 400 mg/m2 of IPI-504 as a 30-minute IV infusion twice weekly for 2 weeks followed by 1 week off with best supportive care. Best supportive care will be according to institutional standard, but will not include administration of systemic cancer-specific therapies including chemotherapies, biologic therapies, investigational therapies, TKIs (e.g., imatinib, sunitinib, nilotinib, dasatinib), or local therapies such as surgery, radiotherapy, or lesion ablative therapies. |
2: Placebo Comparator
Placebo plus best supportive care
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Drug: placebo
30-minute IV infusion twice weekly for 2 weeks followed by 1 week off with best supportive care.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: GIST Phase 3 Team | 877-504-INFI | RINGtrialinfo@infi.com |
United States, California | |
Recruiting | |
Los Angeles, California, United States, 90048 | |
Recruiting | |
Pasadena, California, United States, 91010 | |
Recruiting | |
Los Angeles, California, United States, 90095 | |
United States, Colorado | |
Recruiting | |
Aurora, Colorado, United States, 80045 | |
United States, District of Columbia | |
Recruiting | |
Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
Recruiting | |
Miami Beach, Florida, United States, 33140 | |
United States, Idaho | |
Recruiting | |
Coeur d'Alene, Idaho, United States, 83814 | |
United States, Illinois | |
Recruiting | |
Park Ridge, Illinois, United States, 60068 | |
Recruiting | |
Chicago, Illinois, United States, 60637 | |
United States, Indiana | |
Recruiting | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Recruiting | |
Boston, Massachusetts, United States, 02115 | |
Recruiting | |
Boston, Massachusetts, United States, 02114 | |
United States, Minnesota | |
Recruiting | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Recruiting | |
New York, New York, United States, 10011 | |
United States, North Carolina | |
Recruiting | |
New Bern, North Carolina, United States, 28562 | |
United States, Pennsylvania | |
Recruiting | |
Philadelphia, Pennsylvania, United States, 19046 | |
Australia, South Australia | |
Recruiting | |
Bedford Park, South Australia, Australia, 5042 | |
Recruiting | |
Ashford, South Australia, Australia, 5035 |
Study Director: | Robert Shepard, M.D. | Infinity Pharmaceuticals, Inc. |
Principal Investigator: | George Demetri, MD | Dana-Farber Cancer Institute |
Responsible Party: | Infinity Pharmaceuticals, Inc. ( Project Manager ) |
Study ID Numbers: | IPI-504-06 |
Study First Received: | May 29, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00688766 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
GIST Metastatic and/or Unresectable Gastrointestinal Stromal |
Imatinib Digestive System Diseases Digestive System Neoplasms Sunitinib |
Gastrointestinal Diseases Dasatinib Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |