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Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01091103
First Posted: March 23, 2010
Last Update Posted: September 25, 2017
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.
Collaborators:
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
  Purpose
This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.

Condition Intervention Phase
Metastatic Progressive Castration-resistant Prostate Cancer Drug: Enzalutamide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Of Continuous Oral Dosing Of A Novel Antiandrogen Mdv3100, In Castration-resistant Bone Metastatic Prostate Cancer Patients Evaluating The Tumor Micro-enviroment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Bone Marrow Testosterone [ Time Frame: Baseline, Week 9 ]

    Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.

    Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.


  • Change From Baseline in Bone Marrow Dihydrotestosterone [ Time Frame: Baseline, Week 9 ]

    Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.

    Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.


  • Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status [ Time Frame: Baseline, Week 9 ]

    Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.

    Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.

    The change from baseline in bone marrow testosterone levels at Week 9 was correlated with PSA response status at Week 9.


  • Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status [ Time Frame: Baseline, Week 9 ]

    Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.

    Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.

    The change from baseline in bone marrow dihydrotestosterone levels at Week 9 was correlated with PSA response status at Week 9.



Secondary Outcome Measures:
  • Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA) [ Time Frame: Baseline, Week 9 ]
    Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.

  • Median Time to Study Drug Discontinuation [ Time Frame: Duration of study treatment through the data cutoff, up to 3 years. ]
    Exposure to study drug through the data cutoff of 26AUG2011 only. Fifteen participants (25.0%) were still on study drug as of the data cut-off date and were censored at this date.

  • Change From Baseline in Urinary N-Telopeptide [ Time Frame: Baseline, Week 5 ]
    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5.

  • Change From Baseline in Urinary N-Telopeptide [ Time Frame: Baseline, Week 9 ]
    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9.

  • Change From Baseline in Urinary N-Telopeptide [ Time Frame: Baseline, Week 17 ]
    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17.

  • Change From Baseline in Urinary N-Telopeptide [ Time Frame: Baseline, Week 25 ]
    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25.

  • Change From Baseline in Urinary N-Telopeptide [ Time Frame: Baseline, Week 33 ]
  • Change From Baseline in Urinary N-Telopeptide [ Time Frame: Baseline, Week 41 ]
    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41.

  • Change From Baseline in Urinary N-Telopeptide [ Time Frame: Baseline, Week 49 ]
    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49.

  • Change From Baseline in Urinary N-Telopeptide [ Time Frame: Baseline, Week 57 ]
    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57.

  • Change From Baseline in Urinary N-Telopeptide [ Time Frame: Baseline, Week 65 ]
    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.


Enrollment: 60
Actual Study Start Date: February 18, 2010
Study Completion Date: August 31, 2013
Primary Completion Date: February 29, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide
Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression, unacceptable toxicity, or withdrawal.
Drug: Enzalutamide
Other Name: MDV3100

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed prostate cancer
  • Presence of metastatic disease to the bone
  • Ongoing androgen deprivation therapy

Exclusion Criteria:

  • Severe concurrent disease
  • Metastases in the brain
  Contacts and Locations
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): NCT01091103


Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77303
Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Medical Monitor Medivation, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01091103     History of Changes
Other Study ID Numbers: CRPC-MDA-1
C3431017 ( Other Identifier: Alias Study Number )
First Submitted: March 19, 2010
First Posted: March 23, 2010
Results First Submitted: November 10, 2014
Results First Posted: November 17, 2014
Last Update Posted: September 25, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases