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Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Adenocarcinoma of the Prostate Clinical Trial

Official title:
A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy

Clinical Trial Summary

Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090 works in treating patients with metastatic hormone-resistant prostate cancer previously treated with docetaxel-based chemotherapy

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate progression-free survival (PFS) achieved with STA-9090 (Hsp90 inhibitor STA-9090) in men with castration-resistant prostate cancer (CRPC) who have received prior docetaxel based therapy.

SECONDARY OBJECTIVES:

I. To assess the percentage change in prostate-specific antigen (PSA) from baseline to 12 weeks.

II. To assess overall safety and tolerability of STA-9090. III. To evaluate overall survival (OS) outcome in metastatic CRPC who have received prior docetaxel therapy.

IV. To investigate the association of progression-free survival (PFS) and PSA response rate with primary and secondary target markers.

TERTIARY OBJECTIVES:

I. To evaluate potential markers for predicting drug response or efficacy, blood samples will be used to collect the serum and extract messenger ribonucleic acid (mRNA) from mononuclear cells and analyzed by quantitative real-time polymerase chain reaction (PCR) and/or enzyme-linked immunosorbent assay (ELISA).

OUTLINE:

Patients receive Hsp90 inhibitor STA-9090 intravenously (IV) over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01270880
Study type Interventional
Source Barbara Ann Karmanos Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date January 2011
Completion date July 2014
View Details
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