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Sponsored by: |
Oncology Specialists, S.C. |
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Information provided by: | Oncology Specialists, S.C. |
ClinicalTrials.gov Identifier: | NCT00424385 |
Eligible patients will be enrolled in one of 4 cohorts where each cohort will allow 3 patients to be on study. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. Once the pre-specified 400 mg PO BID dosing for both drugs is reached without toxicity, the study will close for accrual. If toxicity is noted prior to reaching the 400 mg PO BID dosing, then the dosing schedule that is deemed safest as per study design will be the one used for any future phase II study.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Gleevec + Sorafenib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study Investigating the Safety and Feasibility of Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-Independent Chemotherapy-Failure Prostate Cancer. |
Estimated Enrollment: | 18 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Gleevec and Sorafenib
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Drug: Gleevec + Sorafenib
400 mg Sorafenib QD 300mg Gleevec QD
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Gleevec and Sorafenib have modest efficacy in androgen-independent prostate cancer (AIPC) and the fact that both agents can be given orally with what appears to be tolerable side effects, we hypothesize that combining both agents may provide patients with another effective regimen in a disease where therapeutic options are limited. This study is designed to investigate the safety of combining Gleevec and Sorafenib as well as feasibility in AIPC patients who have failed one or more lines of systemic chemotherapy. Once safety is established, a follow-up phase II study will commence to investigate efficacy.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate end organ function, defined as the following:
Patients are allowed the following concurrent therapies:
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 |
Principal Investigator: | Chadi Nabhan, MD | Oncology Specialists, SC |
Responsible Party: | Oncology Specialists, SC ( Chadi Nabhan, MD ) |
Study ID Numbers: | CST1571BUS260 (0617) |
Study First Received: | January 17, 2007 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00424385 |
Health Authority: | United States: Institutional Review Board |
AIPC, Prostate cancer prostate |
Imatinib Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Sorafenib Prostatic Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |