NCT00424385

Study Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-independent Prostate Cancer (AIPC)

Phase I Study Investigating the Safety and Feasibility of Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-Independent Chemotherapy-Failure Prostate Cancer.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Oncology Specialists, S.C. · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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 by mouth two times a day (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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Gleevec + Sorafenib	400 mg Sorafenib every day (QD) 300mg Gleevec QD

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2007-01-19
• Last updated: 2014-07-21
• Results posted: 2014-07-21

Locations

2 sites across 1 country: United States