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Sponsored by: |
Ascenta Therapeutics |
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Information provided by: | Ascenta Therapeutics |
ClinicalTrials.gov Identifier: | NCT00397293 |
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 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Lance Leopold, MD | Ascenta Therapeutics, Inc. |
Responsible Party: | Ascenta Therapeutics, Inc. ( Janet Maleski, Associate Director, Clinical Development ) |
Study ID Numbers: | AT-101-CS-101 |
Study First Received: | November 7, 2006 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00397293 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AT101 AT-101 cancer |
lung small-cell topotecan |
Thoracic Neoplasms Carcinoma, Neuroendocrine Contraceptive Agents Contraceptive Agents, Female Contraceptive Agents, Male Gossypol acetic acid Gossypol Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Retinol acetate Neuroepithelioma Topotecan Adenocarcinoma Acetic Acid Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Contraceptive Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Contraceptive Agents, Female Reproductive Control Agents Contraceptive Agents, Male Gossypol Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Neoplasms, Germ Cell and Embryonal Antispermatogenic Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Gossypol acetic acid Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Lung Diseases Adenocarcinoma Topotecan |