STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling
| Status: | Withdrawn |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2011 |
| End Date: | November 2012 |
A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling
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.
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.
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.
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.
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
We found this trial at
2
sites
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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