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| Sponsor: | Infinity Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Infinity Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00761696 |
Purpose
The primary objectives of the study are:
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: IPI-926 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of IPI-926 in Patients With Advanced and/or Metastatic Solid Tumor Malignancies |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IPI-926
Oral daily dosing
|
Drug: IPI-926
Oral daily dosing
Other Name: Hedgehog pathway inhibitor
|
Study IPI-926-01 is a Phase 1, open-label, dose-escalation study in patients with advanced and/or metastatic solid tumor malignancies.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Treatment with following therapies as indicated:
Venous thromboembolic event (e.g. pulmonary embolism or deep vein thrombosis) requiring anticoagulation or who meet any of the following criteria are excluded:
Contacts and Locations| United States, Arizona | |
| TGen Clinical Research Service at Scottsdale Healthcare | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| Stanford University | |
| Redwood City, California, United States, 94063 | |
| United States, Colorado | |
| University of Colorado Health Science Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Maryland | |
| Johns Hopkins Uninversity | |
| Baltimore, Maryland, United States, 21231 | |
| Canada, Quebec | |
| McGill University Jewish General Hospital | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Study Director: | Robert Ross, MD | Infinity Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Jennifer Sweeney, Infinity Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00761696 History of Changes |
| Other Study ID Numbers: | IPI-926-01 |
| Study First Received: | September 25, 2008 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
solid tumor malignancies |
|
Neoplasms |