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Determine the Effect of Enzalutamide (Formerly MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide to Identify Potential Predictors of Response or Resistance to Therapy

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01091103
First received: March 19, 2010
Last updated: November 10, 2014
Last verified: November 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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-Environment.

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Change From Baseline in Bone Marrow Testosterone [ Time Frame: Baseline, Week 9 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 dihyrdrotestosterone 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 ] [ Designated as safety issue: No ]
    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 date ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Urinary N-Telopeptide [ Time Frame: Baseline, Week 41 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.


Enrollment: 60
Study Start Date: February 2010
Study Completion Date: August 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide Drug: 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.

  Eligibility

Genders Eligible for Study:   Male
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091103

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77303
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01091103     History of Changes
Other Study ID Numbers: CRPC-MDA-1
Study First Received: March 19, 2010
Results First Received: November 10, 2014
Last Updated: November 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014