NCT01270880

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Adenocarcinoma of the Prostate
• Hormone-resistant Prostate Cancer
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	Hsp90 inhibitor STA-9090	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
GENETIC	polymerase chain reaction	Correlative studies
OTHER	enzyme-linked immunosorbent assay	Correlative studies
GENETIC	RNA analysis	Correlative studies
OTHER	spectrophotometry	Correlative studies
GENETIC	reverse transcriptase-polymerase chain reaction	Correlative studies
GENETIC	gene expression analysis	Correlative studies

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-01-05
• Last updated: 2018-09-18
• Results posted: 2015-04-14

Locations

4 sites across 1 country: United States