Clinical trial NCT01368003: STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling
Official title: A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Adenocarcinoma of the Prostate
Keywords: Castration resistant prostate cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Adenocarcinoma of the prostate
* Progressive castration resistant disease
* Metastatic disease
* Normal organ and marrow function

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: To assess the safety and tolerability of STA9090 in men the CRPC
timeFrame: 2 years
measure: To evaluate progression-free survival (PFS) of men with CRPC treated with STA9090 with or without dutasteride
timeFrame: 2 years
measure: To evaluate the overall survival of men with metastatic CRPC treated with STA9090 alone or in combination with dutasteride
timeFrame: 2 years
measure: To determine the response rate of measurable disease if present (RECIST)
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Toni K Choueiri, MD
role: PRINCIPAL_INVESTIGATOR
References: