Study Stopped
Loss of funding.
STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling
A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
June 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedSeptember 1, 2015
August 1, 2015
1.6 years
April 21, 2011
August 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
2 years
Secondary Outcomes (4)
To assess the safety and tolerability of STA9090 in men the CRPC
2 years
To evaluate progression-free survival (PFS) of men with CRPC treated with STA9090 with or without dutasteride
2 years
To evaluate the overall survival of men with metastatic CRPC treated with STA9090 alone or in combination with dutasteride
2 years
To determine the response rate of measurable disease if present (RECIST)
2 years
Study Arms (2)
STA9090 with Dutasteride
EXPERIMENTALSTA9090 with Dutasteride
STA9090
EXPERIMENTALSTA9090
Interventions
200 mg/m\^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)
Dutasteride 3.5 mg orally per day STA9090 200 mg/m\^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)
Eligibility Criteria
You may qualify if:
- Adenocarcinoma of the prostate
- Progressive castration resistant disease
- Metastatic disease
- Normal organ and marrow function
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Toni K Choueiri, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Overall Investigator
Study Record Dates
First Submitted
April 21, 2011
First Posted
June 7, 2011
Study Start
April 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
September 1, 2015
Record last verified: 2015-08