Study Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-independent Prostate Cancer (AIPC)
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|ClinicalTrials.gov Identifier: NCT00424385|
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Gleevec + Sorafenib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||January 2007|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
Experimental: Arm 1
Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
Drug: Gleevec + Sorafenib
400 mg Sorafenib every day (QD) 300mg Gleevec QD
Other Name: Imatinib mesylate; Nexavar
- Number of Patients Experiencing Dose Limiting Toxicities (DLT's) [ Time Frame: up to 20 weeks ]Eligible patients were enrolled in one of 4 cohorts, where each cohort allowed 3 evaluable patients to be on study, patients withdrawn from treatment for reasons other than toxicity were not considered evaluable. If one of the three evaluable patients experienced a dose limiting toxicity (DLT) the cohort was expanded to 6 evaluable patients. 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. If 2 out of six evaluable patients experience a dose limiting toxicity this would show that the Maximum Tolerated Dose (MTD) was the dose from the prior cohort.
- Overall Clinical Benefit [ Time Frame: up to 20 weeks ]Overall Clinical Benefit was measured as the sum of complete response (CR), partial response (PR), and stable disease (SD).
- Time to Disease Progression (TTP) [ Time Frame: up to 5 cycles, an average of 20 weeks, from the day of first treatment until the date of the last dose of study drug ]Medium TTP is 2 months (range 1-5). 10 patients were evaluable for disease progression for these patients occurred between 1-5 months after starting the study. The TTP was calculated per protocol. For radiographic assessment Response Evaluation Criteria in Solid Tumors (RECIST) was used. Complete response = disappearance of all lesions. Partial response (PR)=30% or greater decrease in sum of longest diameter of measureable lesions SD. Lesions have no sufficient decrease for progressive disease and no sufficient increase to meet Progressive Disease (PD). PD more than 20% increase in sum of longest diameter of measurable lesions or 2 or more new bone mets. prostate-specific antigen (PSA) assessment for patients with measurable disease, PSA progression in the absence of measurable disease progression will not be considered progressive disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424385
|United States, Illinois|
|Oncology Specialists, S.C|
|Niles, Illinois, United States, 60714|
|Oncology Specialists, S.C|
|Park Ridge, Illinois, United States, 60068|
|Principal Investigator:||Chadi Nabhan, MD||Oncology Specialists, SC|