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

Sponsor

Toni Choueiri, MD (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01368003

Collaborator

(none)

Enrollment

Locations

Arms

19.1

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Prostate	Drug: STA9090 Drug: STA9090 with Dutasteride	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STA9090 with Dutasteride STA9090 with Dutasteride	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) Other Names: Avodart
Experimental: STA9090 STA9090	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)

Arm

Intervention/Treatment

Experimental: STA9090 with Dutasteride

STA9090 with Dutasteride

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)

Other Names:

Avodart

Experimental: STA9090

STA9090

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)

Outcome Measures

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. [2 years]
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 [2 years]
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 [2 years]
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 [2 years]
OS will be summarized using K-M method.
To determine the response rate of measurable disease if present (RECIST) [2 years]
Patients with measurable disease will be evaluated for response using RECIST criteria and summarized descriptively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Toni Choueiri, MD

Investigators

Principal Investigator: Toni K Choueiri, MD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Toni Choueiri, MD, Overall Investigator, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT01368003

Other Study ID Numbers:

10-333

First Posted:

Jun 7, 2011

Last Update Posted:

Sep 1, 2015

Last Verified:

Aug 1, 2015

Keywords provided by Toni Choueiri, MD, Overall Investigator, Dana-Farber Cancer Institute

Castration resistant prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Dutasteride

Study Results

No Results Posted as of Sep 1, 2015