Temsirolimus In Phase 0
The goal of this clinical research trial is to study the effects of the FDA-approved drug, temsirolimus, using a new type of clinical study design called a "Phase 0." This type of study may be able to predict if a drug can affect cancer and may be able to prevent potentially useful study drugs from being discarded before they are fully tested.
The purpose of the study is not to treat the cancer, but to help improve general cancer treatment knowledge.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 0 Trial Evaluating the Effect of Temsirolimus on Known Pharmacodynamic Targets|
- Participants' Pharmacodynamic (PD) Responses [ Time Frame: Blood drawn at 4 hours (+/- 2 hours) after study drug ] [ Designated as safety issue: No ]PD response, significant S6 Kinase 1 (S6K1) inhibition, is defined at both the patient level and the dose level, 1) as compared with baseline, at least 50% reductions of S6K1 after treatment (biological criterion); 2) differences in log transformed S6K1 activity between post-treatment and baseline should be greater than threshold of 1.8 times standard deviation (SD) of baseline, which yields a 90% statistical confidence that it is not due to chance variation (statistical criterion).
|Study Start Date:||August 2010|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Starting dose 0.02 mg intravenous administered once.
Starting dose will be 0.02 mg intravenous administered once on Day 1 over 60 minutes.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01417065
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Daniel Karp, MD||UT MD Anderson Cancer Center|