Temsirolimus In Phase 0
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|ClinicalTrials.gov Identifier: NCT01417065|
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : June 23, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: Temsirolimus||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 0 Trial Evaluating the Effect of Temsirolimus on Known Pharmacodynamic Targets|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 2014|
Starting dose 0.02 mg intravenous administered once.
Starting dose will be 0.02 mg intravenous administered once on Day 1 over 60 minutes.
- Participants' Pharmacodynamic (PD) Responses [ Time Frame: Blood drawn at 4 hours (+/- 2 hours) after study drug ]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).
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): NCT01417065
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Daniel Karp, MD||UT MD Anderson Cancer Center|