NCT01020305|TerminatedPhase 1/2ResultsDMC
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Decision by funding sponsor due to poor accrual
Temsirolimus, an mTOR Inhibitor, to Reverse Androgen Insensitivity in Patients With Castration-resistant Prostate Cancer
Sponsor study identifier
Secondary identifiers
OTHER · NIH
OTHER · Stanford University
OTHER · OnCore
interventional
5
1 country
1
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)This study evaluates if temsirolimus causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 30, 2009
Actual (reported)November 25, 2009
Actual (reported)April 2012
Actual (reported)April 2012
Actual (reported)October 13, 2014
Actual (reported)Reduction in Serum PSA
Proportion of subjects with \> 50% drop in serum PSA as compared to baseline, assessed at 16 weeks
12 weeks treatment, with primary outcome assessed at 16 weeks
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks Casodex (bicalutamide) administered 50 mg/day orally (PO)
Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942) IUPAC name: (1R,2R,4S)-4-{(2R)-2-\[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido\[2,1-c\]\[1,4\]oxazacyclohentriacontin-3-yl\]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate
Stanford University School of Medicine
Stanford, California, 94305, United States
Sandhya "Sandy" Srinivas, MD
Stanford University
Lauren Christine Harshman, MD
Stanford University
5 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2009
First Posted
November 25, 2009
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Casodex (bicalutamide) 50 mg/day PO
Contact the study team to confirm eligibility.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)Last Updated
October 13, 2014
Results First Posted
October 13, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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