STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling
- Conditions
- Adenocarcinoma of the Prostate
- Interventions
- Registration Number
- NCT01368003
- Lead Sponsor
- Toni Choueiri, MD
- Brief Summary
In this research study, the investigators are looking to determine the safety and efficacy of an investigational drug, STA9090 alone and in combination with dutasteride for the treatment of castrate resistant prostate cancer. STA9090 may cause the growth of cancer to slow down or shrink by targeting proteins required for the cancer to grow. The investigators are also looking to determine whether the use of dutasteride to lower male hormone levels will enhance the effect of STA9090 in the treatment of castrate resistant prostate cancer.
- Detailed Description
Subjects will have a tumor biopsy before treatment begins. Subjects who are randomized to Arm A will receive infusions of STA9090 on days 1, 8, and 15 of a 28 day cycle. Subjects randomized on Arm B will receive daily oral dutasteride for 2 weeks prior to beginning STA9090 treatment. They will continue to receive dutasteride while on study.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
- Adenocarcinoma of the prostate
- Progressive castration resistant disease
- Metastatic disease
- Normal organ and marrow function
- History of current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass
- Current treatment with the following antiarrhythmic drugs: flecainide, moricizine or propafenone
- New York Heart Association class II/III/IV congestive heart failure
- Current or prior radiation therapy to the left hemithorax
- Treatment with chronic immunosuppressants
- Uncontrolled intercurrent illness
- Poor venous access for study drug administration
- Venous thromboembolism in the past 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STA9090 STA9090 STA9090 STA9090 with Dutasteride STA9090 with Dutasteride STA9090 with Dutasteride
- Primary Outcome Measures
Name Time Method To assess AR transcriptional activity based on expression of a series of AR regulated genes, in baseline and on therapy tumor biopsies in CRPC patients treated with STA- 9090 +/-dutasteride. 2 years The primary objective is to determine whether STA-9090, or the combination with dutasteride further suppresses AR transcriptional activity. AR transcriptional activity will be assessed based on expression of a series of AR regulated genes, in baseline and on therapy tumor biopsies in CRPC patients treated with STA-9090 +/- dutasteride.
- Secondary Outcome Measures
Name Time Method To evaluate progression-free survival (PFS) of men with CRPC treated with STA9090 with or without dutasteride 2 years PFS will be summarized using K-M method.
To determine the response rate of measurable disease if present (RECIST) 2 years Patients with measurable disease will be evaluated for response using RECIST criteria and summarized descriptively.
To assess the safety and tolerability of STA9090 in men the CRPC 2 years Each type of toxicity rate (a proportion) will be analyzed and summarized descriptively.
To evaluate the overall survival of men with metastatic CRPC treated with STA9090 alone or in combination with dutasteride 2 years OS will be summarized using K-M method.
Trial Locations
- Locations (2)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States