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Sponsors and Collaborators: |
Celgene Corporation Prologue Research International |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00179712 |
Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-14 when given with topotecan on days 1-5 of every 21 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-14 with topotecan on days 1-5 in 21 day cycles until disease progression is documented.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: CC-5013 Drug: topotecan |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid®) With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma |
Estimated Enrollment: | 60 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | November 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following laboratory abnormalities:
United States, Georgia | |
Medical College of GeorgiaDept of OBGYN | |
Augusta, Georgia, United States, 30912-3335 | |
United States, Minnesota | |
University of MinnesotaObstetrics & Gynecology, MMC | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 |
Study ID Numbers: | CC-5013-OVRY-002 |
Study First Received: | September 10, 2005 |
Last Updated: | December 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00179712 |
Health Authority: | United States: Food and Drug Administration |
cc-5013 revlimid ovarian cancer celgene |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Lenalidomide Endocrine System Diseases Urogenital Neoplasms |
Ovarian Diseases Carcinoma Genital Diseases, Female Endocrinopathy Topotecan Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Adnexal Diseases |