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| Sponsor: | Vertex Pharmaceuticals Incorporated |
|---|---|
| Information provided by (Responsible Party): | Vertex Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT00493441 |
Purpose
The study will find the optimum AVN944 dose to use in combination with gemcitabine in patients with pancreatic cancer and see if the combination of the 2 drugs is more effective for treating pancreatic cancer than using gemcitabine alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: AVN944 |
Phase II |
| 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 II Study of AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer |
| Enrollment: | 28 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, hepatic and renal function as evidenced by:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tuscon, Arizona, United States, 85715 | |
| United States, California | |
| University of Southern California - Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| California Pacific Medical Center Research Institute | |
| San Francisco, California, United States, 94115 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06520 | |
| United States, District of Columbia | |
| Georgetown University, Lombardi Comprehensive Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| University of Florida - Shands Cancer Center | |
| Gainesville, Florida, United States, 32610 | |
| United States, Georgia | |
| Emory University - Winship Cancer Institute | |
| Altanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Joliet Oncology and Hematology Associates | |
| Joliet, Illinois, United States, 60435 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| Hematology Oncology Associates of Rockland | |
| Nyack, New York, United States, 10960 | |
| United States, Ohio | |
| Cleveland Clinic - Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Tennessee | |
| Chattanooga Oncology and Hematology Associates | |
| Chattanooga, Tennessee, United States, 37404 | |
| University of Tennessee Medical Center | |
| Knoxville, Tennessee, United States, 37920 | |
| Sarah Cannon Research Institute -Tennessee Oncology | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Virginia | |
| Virginia Cancer institute | |
| Richmond, Virginia, United States, 23230 | |
More Information
| Responsible Party: | Vertex Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT00493441 History of Changes |
| Other Study ID Numbers: | AVN944-006 |
| Study First Received: | June 26, 2007 |
| Last Updated: | September 21, 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 |