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| Sponsor: | Point Therapeutics |
|---|---|
| Information provided by: | Point Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00080080 |
Purpose
The purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: talabostat (PT-100) tablets Drug: Docetaxel |
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: | Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Total bilirubin ≥institutional upper limit of normal (ULN); Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN; Hepatitis B surface antigen or antibody to Hepatitis C (anti-HCV antibody); Serum creatinine ≥2.0mg/dL; or Granulocytes <1500/μL or platelets <100,000/μL.
Contacts and Locations| United States, Florida | |
| Cancer Center of Florida | |
| Ocoee, Florida, United States, 34761 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Michigan | |
| Van Elslander Cancer Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| United States, New York | |
| New York Oncology/Hematology--Albany Regional Cancer Center | |
| Albany, New York, United States, 12208 | |
| Mt. Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| USB Cancer Center-- Nyack Hospital | |
| Nyack, New York, United States, 10960 | |
| United States, Ohio | |
| Dayton Oncology & Hematology | |
| Kettering, Ohio, United States, 45409 | |
| United States, Texas | |
| Mary Crowley Medical Research Center | |
| Dallas, Texas, United States, 75246 | |
| Tyler Cancer Center | |
| Tyler, Texas, United States, 75702 | |
| United States, Washington | |
| Cancer Care Northwest | |
| Spokane, Washington, United States, 99218 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00080080 History of Changes |
| Other Study ID Numbers: | PTH-302 |
| Study First Received: | March 23, 2004 |
| Last Updated: | June 7, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |