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Sponsors and Collaborators: |
Oncology Specialists, S.C. Celgene Corporation |
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Information provided by: | Oncology Specialists, S.C. |
ClinicalTrials.gov Identifier: | NCT00654186 |
This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve. Patients will receive Revlimid® 25 mg daily on Days 1-21 followed by 7 days of rest repeated every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Revlimid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study Evaluating the Toxicity and Efficacy of Single Agent Lenalidomide (Revlimid®) in Chemotherapy-Naïve Androgen-Independent Prostate Cancer Patients |
Estimated Enrollment: | 25 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Revlimid
25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients need to have adequate bone marrow function.
Exclusion Criteria:
Contact: Kathy Tolzien, RN | 847-410-0658 | ktolzien@oncmed.net |
Contact: Phillip Gozun | 847-410-0662 | pgozun@oncmed.net |
United States, Illinois | |
Oncology Specialists, S.C | Recruiting |
Niles, Illinois, United States, 60714 | |
Contact: Kathy Tolzien, RN 847-410-0658 ktolzien@oncmed.net |
Principal Investigator: | Chadi Nabhan, MD | Oncology Specialists, SC |
Responsible Party: | Oncology Specialists, S.C ( Chadi Nabhan, MD ) |
Study ID Numbers: | RV-PCA-PI-327 |
Study First Received: | April 2, 2008 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00654186 |
Health Authority: | United States: Institutional Review Board |
Androgen Independent Prostate Cancer (AIPC) Chemo naive |
Prostatic Diseases Genital Neoplasms, Male Lenalidomide |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |