CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
Gleevec + Sorafenibdrug
Likely dose
Gleevec + Sorafenib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00424385
NCT00424385Phase 1Completed

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

Oncology Specialists, S.C.·interventional·Posted Jan 19, 2007·Updated Jul 21, 2014

In Brief

A Phase 1 clinical trial evaluating Gleevec + Sorafenib for Prostate Cancer. Completed, enrolled 17 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 19, 2007
Enrollment StartJan 1, 2007
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 19.5 years ago

Interventions

Gleevec + Sorafenibdrug

400 mg Sorafenib every day (QD) 300mg Gleevec QD