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

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ClinicalTrials.gov Identifier: NCT01368003
Recruitment Status : Withdrawn (Loss of funding.)
First Posted : June 7, 2011
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Toni Choueiri, MD, Dana-Farber Cancer Institute

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : April 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. To assess the safety and tolerability of STA9090 in men the CRPC [ Time Frame: 2 years ]
    Each type of toxicity rate (a proportion) will be analyzed and summarized descriptively.

  2. To evaluate progression-free survival (PFS) of men with CRPC treated with STA9090 with or without dutasteride [ Time Frame: 2 years ]
    PFS will be summarized using K-M method.

  3. To evaluate the overall survival of men with metastatic CRPC treated with STA9090 alone or in combination with dutasteride [ Time Frame: 2 years ]
    OS will be summarized using K-M method.

  4. To determine the response rate of measurable disease if present (RECIST) [ Time Frame: 2 years ]
    Patients with measurable disease will be evaluated for response using RECIST criteria and summarized descriptively.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368003


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Toni Choueiri, MD
Investigators
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Principal Investigator: Toni K Choueiri, MD Dana-Farber Cancer Institute
More Information
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Responsible Party: Toni Choueiri, MD, Overall Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01368003     History of Changes
Other Study ID Numbers: 10-333
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Keywords provided by Toni Choueiri, MD, Dana-Farber Cancer Institute:
Castration resistant prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Androgens
Dutasteride
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists