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| Sponsor: | Ascenta Therapeutics |
|---|---|
| Information provided by: | Ascenta Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00397293 |
Purpose
This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: AT-101 Drug: topotecan |
Phase I 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: | An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy |
| Enrollment: | 36 |
| Study Start Date: | November 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Further Study Details provided by Ascenta:
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 19 Study Locations| Study Chair: | Lance Leopold, MD | Ascenta Therapeutics, Inc. |
More Information
| Responsible Party: | Janet Maleski, Associate Director, Clinical Development, Ascenta Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00397293 History of Changes |
| Other Study ID Numbers: | AT-101-CS-101 |
| Study First Received: | November 7, 2006 |
| Last Updated: | August 20, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
AT101 AT-101 cancer |
lung small-cell topotecan |
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gossypol Gossypol acetic acid Topotecan Contraceptive Agents, Male |
Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antineoplastic Agents, Phytogenic Antineoplastic Agents Contraceptive Agents, Female Spermatocidal Agents Antispermatogenic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |