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A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling


Phase 2
18 Years
N/A
Not Enrolling
Male
Adenocarcinoma of the Prostate

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Trial Information

A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome 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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Toni K Choueiri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

10-333

NCT ID:

NCT01368003

Start Date:

April 2011

Completion Date:

December 2012

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Castration resistant prostate cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115