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Trial record 41 of 117 for:    DUTASTERIDE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Loss of funding.)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

Tracking Information
First Submitted Date  ICMJE April 21, 2011
First Posted Date  ICMJE June 7, 2011
Last Update Posted Date September 1, 2015
Study Start Date  ICMJE April 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01368003 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling
Official Title  ICMJE A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma of the Prostate
Intervention  ICMJE
  • 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)
  • 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
Study Arms  ICMJE
  • Experimental: STA9090 with Dutasteride
    STA9090 with Dutasteride
    Intervention: Drug: STA9090 with Dutasteride
  • Experimental: STA9090
    STA9090
    Intervention: Drug: STA9090
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 20, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2011)
30
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01368003
Other Study ID Numbers  ICMJE 10-333
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Toni Choueiri, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Toni Choueiri, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Toni K Choueiri, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP