NCT01417065|CompletedEarly Phase 1
Temsirolimus In Phase 0
Phase 0 Trial Evaluating the Effect of Temsirolimus on Known Pharmacodynamic Targets
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Phase 0 Trial Evaluating the Effect of Temsirolimus on Known Pharmacodynamic Targets
Sponsor study identifier
Secondary identifiers
REGISTRY · NCI CTRP
interventional
15
1 country
1
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
Not reported
Date not reportedThe 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
August 12, 2011
Actual (reported)August 16, 2011
Actual (reported)June 2014
Actual (reported)Participants' Pharmacodynamic (PD) Responses
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).
Blood drawn at 4 hours (+/- 2 hours) after study drug
Starting dose 0.02 mg intravenous administered once.
Starting dose will be 0.02 mg intravenous administered once on Day 1 over 60 minutes.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Daniel Karp, MD
UT MD Anderson Cancer Center
15 participants (actual enrollment reported by the registry).
First Submitted
August 12, 2011
First Posted
August 16, 2011
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Bevacizumab and Temsirolimus in Patients With Advanced Malignancy
Contact the study team to confirm eligibility.
Primary Completion
June 2014
Actual (reported)Last Updated
June 23, 2014
Record last verified: 2014-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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