Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma
|ClinicalTrials.gov Identifier: NCT00349206|
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : April 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Recurrent Melanoma Stage III Melanoma Stage IV Melanoma||Drug: sorafenib tosylate Drug: temsirolimus||Phase 1|
I. To determine the maximum tolerated dose of temsirolimus when administered with sorafenib in patients with metastatic, recurrent, or unresectable melanoma.
II. To determine the safety and toxicity of this regimen in these patients.
I. To Determine the population pharmacokinetics of this regimen in these patients.
II. To correlate tumor and blood biomarkers with clinical outcome in patients treated with this regimen.
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II, open-label study (2005-0215).
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and oral sorafenib once or twice daily on days 1-28. Treatment course repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of the Combination of BAY 43-9006 (Sorafenib) and CCI-779 (Temsirolimus) in Patients With Metastatic Melanoma|
|Study Start Date :||April 2006|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
U.S. FDA Resources
Experimental: Arm 1
Patients receive temsirolimus IV over 30 minutes on days 1, 8,15, and 22 and oral sorafenib once or twice daily on days 1-28.
Drug: sorafenib tosylate
Other Names:Drug: temsirolimus
- Maximum tolerated dose of CCI-779 in combination with BAY43-9006 (Phase I) determined by DLT assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: 28 days ]
- Objective response rate (complete response and partial response) CCI-779 in combination with BAY43-9006 (Phase II) [ Time Frame: Up to 5 years ]
- Progression-free survival [ Time Frame: The duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress, assessed up to 5 years ]Kaplan-Meier life table methods and Cox proportional hazards regression modeling will be utilized to analyze progression-free survival and overall survival.
- Overall survival [ Time Frame: 5 years ]Kaplan-Meier life table methods and Cox proportional hazards regression modeling will be utilized to analyze progression-free survival and overall survival.
- Noncompartmental pharmacokinetic parameters of BAY43-9006 and CCI-779 estimated using a validated commercial software [ Time Frame: Week 1 and 3 ]Maximum concentration (Cmax) and time to Cmax (tmax) will be the observed values. Area under the plasma concentration-time curve from zero to last observable time (AUClast).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349206
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Kevin Kim||M.D. Anderson Cancer Center|