Who is sponsoring NCT00887640?

NCT00887640 is sponsored by Duke University.

What condition does NCT00887640 study?

NCT00887640 studies Prostate Cancer.

What drugs are being tested in NCT00887640?

Interventions: Temsirolimus, Diphenhydramine.

What is the status of NCT00887640?

NCT00887640 is currently TERMINATED.

Last reviewed 2014-01-24 · How we verify

Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology In Men With Castration Resistant Metastatic Prostate Cancer

NCT00887640 Phase 2 TERMINATED Results posted

This is a single arm study of 11 men with treatment refractory metastatic Castrate Resistant Prostate Cancer (CRPC) who will receive temsirolimus IV at a dose of 25 mg weekly until progression. Progression will not include Prostate Specific Antigen (PSA) progression; however, upon PSA progression, the addition of an anti-androgen will be permitted. The primary objective of the study is to evaluate change in circulating tumor cell (CTC) counts over time in men with metastatic treatment-refractory CRPC in response to temsirolimus therapy.

Details

Lead sponsor	Duke University
Phase	Phase 2
Status	TERMINATED
Enrolment	11
Start date	2009-07
Completion	2012-08

Conditions

Prostate Cancer

Interventions

Temsirolimus
Diphenhydramine

Primary outcomes

Change in Circulating Tumor Cell (CTC) Counts in Men With Metastatic Treatment-refractory Castration-resistant Prostate Cancer. — Baseline to 8 weeks
Median percent change in CTC count from baseline to 8 weeks of treatment. Percent change was calculated by determining the percentage increase or decrease in CTC count from baseline.

Countries

United States