Back to resultsSTA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling
Primary Purpose
Adenocarcinoma of the Prostate
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
STA9090
STA9090 with Dutasteride
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring Castration resistant prostate cancer
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
Sites / Locations
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
STA9090 with Dutasteride
STA9090
Arm Description
STA9090 with Dutasteride
STA9090
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To assess the safety and tolerability of STA9090 in men the CRPC
Each type of toxicity rate (a proportion) will be analyzed and summarized descriptively.
To evaluate progression-free survival (PFS) of men with CRPC treated with STA9090 with or without dutasteride
PFS will be summarized using K-M method.
To evaluate the overall survival of men with metastatic CRPC treated with STA9090 alone or in combination with dutasteride
OS will be summarized using K-M method.
To determine the response rate of measurable disease if present (RECIST)
Patients with measurable disease will be evaluated for response using RECIST criteria and summarized descriptively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01368003
Brief Title
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
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Loss of funding.
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Toni Choueiri, MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate
Keywords
Castration resistant prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STA9090 with Dutasteride
Arm Type
Experimental
Arm Description
STA9090 with Dutasteride
Arm Title
STA9090
Arm Type
Experimental
Arm Description
STA9090
Intervention Type
Drug
Intervention Name(s)
STA9090
Intervention Description
200 mg/m^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)
Intervention Type
Drug
Intervention Name(s)
STA9090 with Dutasteride
Other Intervention Name(s)
Avodart
Intervention Description
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)
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of STA9090 in men the CRPC
Description
Each type of toxicity rate (a proportion) will be analyzed and summarized descriptively.
Time Frame
2 years
Title
To evaluate progression-free survival (PFS) of men with CRPC treated with STA9090 with or without dutasteride
Description
PFS will be summarized using K-M method.
Time Frame
2 years
Title
To evaluate the overall survival of men with metastatic CRPC treated with STA9090 alone or in combination with dutasteride
Description
OS will be summarized using K-M method.
Time Frame
2 years
Title
To determine the response rate of measurable disease if present (RECIST)
Description
Patients with measurable disease will be evaluated for response using RECIST criteria and summarized descriptively.
Time Frame
2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toni K Choueiri, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling
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