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| Sponsor: | Infinity Pharmaceuticals, Inc. |
|---|---|
| Information provided by (Responsible Party): | Infinity Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01130142 |
Purpose
Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2 portion will commence.
Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there is no option for patients receiving placebo to cross-over to IPI-926).
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Pancreatic Cancer |
Drug: IPI-926 plus gemcitabine Drug: Placebo plus gemcitabine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer |
| Estimated Enrollment: | 130 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1 (Phase 2)
IPI-926 in combination with gemcitabine
|
Drug: IPI-926 plus gemcitabine
Daily IPI-926 (oral) at 160 mg plus gemcitabine (infusion) at 1000 mg/m2 once weekly for 3 weeks of a 28 day cycle
Other Names:
|
|
Placebo Comparator: Arm 2 (Phase 2)
Placebo in combination with gemcitabine
|
Drug: IPI-926 plus gemcitabine
Daily IPI-926 (oral) at 160 mg plus gemcitabine (infusion) at 1000 mg/m2 once weekly for 3 weeks of a 28 day cycle
Other Names:
Drug: Placebo plus gemcitabine
Daily Oral placebo/IPI-926 160 mg plus gemcitabine infusion at 1000 mg/m2 once every 3 weeks in a 28 day cycle
Other Names:
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IPI 926 is an inhibitor of the Hedgehog Pathway. IPI-926 in combination with gemcitabine may improve therapeutic outcomes in patients with pancreatic cancer. Infinity is conducting a Phase 1b/2 clinical trial to evaluate the safety and efficacy of IPI-926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer.
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
Show 28 Study Locations| Study Director: | Robert Ross, MD | Infinity Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Infinity Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01130142 History of Changes |
| Other Study ID Numbers: | IPI-926-03 |
| Study First Received: | April 21, 2010 |
| Last Updated: | November 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |