MedTrace Logo

Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

NCT01020305 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-10-13

Study results available
· View outcomes & findings →

Summary

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).

Conditions

  • Prostate Cancer
  • Prostatic Neoplasms
  • Castrate-resistant Prostate Cancer (CRPC)
  • Androgen-insensitive Prostate Cancer
  • Hormone-refractory Prostate Cancer
  • Metastatic Disease

Interventions

DRUG

Temsirolimus

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

DRUG

Casodex (bicalutamide)

Casodex (bicalutamide) 50 mg/day PO

Sponsors & Collaborators

Principal Investigators

  • Sandhya "Sandy" Srinivas, MD · Stanford University

  • Lauren Christine Harshman, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01020305 on ClinicalTrials.gov