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| Sponsor: | Infinity Pharmaceuticals, Inc. |
|---|---|
| Information provided by (Responsible Party): | Infinity Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01310816 |
Purpose
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Conventional Chondrosarcoma |
Drug: IPI-926 Drug: Placebo Arm |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma |
| Estimated Enrollment: | 140 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: IPI-926
IPI-926
|
Drug: IPI-926
Oral
|
|
Placebo Comparator: Sugar Pill
Placebo Arm, sugar pill
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Drug: Placebo Arm
oral placebo
|
Study IPI-926-04 is a Phase 2, double-blind, placebo-controlled, multicenter, trial evaluating the safety and efficacy of IPI-926 in patients with metastatic or locally advanced (unresectable) chondrosarcoma. The study includes an optional cross-over to open-label IPI-926 for patients randomly assigned to placebo who experience documented disease progression.
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 48 Study Locations
More Information
| Responsible Party: | Infinity Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01310816 History of Changes |
| Other Study ID Numbers: | IPI-926-04 |
| Study First Received: | March 3, 2011 |
| Last Updated: | May 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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malignant neoplasms of the bone bone sarcoma |
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Chondrosarcoma Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Sarcoma |