STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling

NCT ID: NCT01368003

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-11-30

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.

Conditions

Adenocarcinoma of the Prostate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STA9090 with Dutasteride

STA9090 with Dutasteride

Group Type: EXPERIMENTAL

STA9090 with Dutasteride

Intervention Type: DRUG

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)

STA9090

STA9090

Group Type: EXPERIMENTAL

STA9090

Intervention Type: DRUG

200 mg/m\^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)

Interventions

STA9090

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

STA9090 with Dutasteride

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)

Intervention Type: DRUG

Other Intervention Names

Avodart

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Toni Choueiri, MD

OTHER

Sponsor Role: lead

Responsible Party

Toni Choueiri, MD

Overall Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Toni K Choueiri, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

10-333

Identifier Type: -

Identifier Source: org_study_id