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

Adenocarcinoma of the Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01368003
• Other study ID #: 10-333
• Status: Withdrawn
• Phase: Phase 2
• First received: April 21, 2011
• Last updated: August 29, 2015
• Start date: April 2011
• Est. completion date: November 2012

Study information

• Verified date: August 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms

Intervention

Drug:
• 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 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)

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Toni Choueiri, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	2 years	Yes
Secondary	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.	2 years	No
Secondary	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.	2 years	No
Secondary	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.	2 years	No