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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Adenocarcinoma of the Prostate
• Intervention / Treatment: Drug: STA9090 with Dutasteride; Drug: STA9090

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Estimate): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 29, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Castration resistant prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: 10-333