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

Purpose

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	Intervention	Phase
Adenocarcinoma of the Prostate	Drug: STA9090 Drug: STA9090 with Dutasteride	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Dutasteride

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
OS will be summarized using K-M method.
To determine the response rate of measurable disease if present (RECIST) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Patients with measurable disease will be evaluated for response using RECIST criteria and summarized descriptively.

Enrollment:	0
Study Start Date:	April 2011
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368003

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Toni Choueiri, MD

Investigators

Principal Investigator:

Toni K Choueiri, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Toni Choueiri, MD, Overall Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT01368003 History of Changes
Other Study ID Numbers:	10-333
Study First Received:	April 21, 2011
Last Updated:	December 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

Castration resistant prostate cancer

Additional relevant MeSH terms:

Adenocarcinoma
Adenocarcinoma, Mucinous
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Genital Diseases, Male
Prostatic Diseases
Androgens
Dutasteride
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013