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Sponsored by: |
Ascenta Therapeutics |
---|---|
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 |
Estimated Enrollment: | 94 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 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: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00397293 |
Health Authority: | United States: Food and Drug Administration |
AT101 AT-101 cancer |
lung small-cell topotecan |
Thoracic Neoplasms Carcinoma, Neuroendocrine Gossypol acetic acid Gossypol Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Topotecan Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Contraceptive Agents Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Contraceptive Agents, Female Enzyme Inhibitors |
Reproductive Control Agents Contraceptive Agents, Male Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Antispermatogenic Agents Spermatocidal Agents Antineoplastic Agents, Phytogenic |