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Sponsors and Collaborators: |
Celgene Corporation Prologue Research International |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00179686 |
Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day cycles. Subjects will continue until disease progression is documented.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: CC-5013 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid, CC-5013) in Subjects With Recurrent Non-Small Cell Lung Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
WCBP must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug.
Exclusion Criteria:
Any of the following laboratory abnormalities:
United States, Alabama | |
Birmingham Cancer Center | |
Birmingham, Alabama, United States, 35294 | |
United States, Illinois | |
Rush Cancer Institute | |
Chicago, Illinois, United States, 60612 | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Louisiana | |
Cancer and Blood Institute | |
Metairie, Louisiana, United States, 70006 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study ID Numbers: | CC-5013-NSCL-001 |
Study First Received: | September 10, 2005 |
Last Updated: | December 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00179686 |
Health Authority: | United States: Food and Drug Administration |
celgene cc-5013 NSCLC |
CC5013 Revlimid Non-Small Cell Lung Cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Lenalidomide Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |