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

NCT01091103 | Completed Phase 2 Results

• 2 other identifiers: CRPC-MDA-1C3431017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Progressive Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Bone Marrow Testosterone

  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.

  Baseline, Week 9

• Change From Baseline in Bone Marrow Dihydrotestosterone

  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.

  Baseline, Week 9

• Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status

  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.

  Baseline, Week 9

• Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status

  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.

  Baseline, Week 9

Secondary Outcomes (11)

• Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)

  Baseline, Week 9

• Median Time to Study Drug Discontinuation

  Duration of study treatment through the data cutoff, up to 3 years.

• Change From Baseline in Urinary N-Telopeptide

  Baseline, Week 5

• Change From Baseline in Urinary N-Telopeptide

  Baseline, Week 9

• Change From Baseline in Urinary N-Telopeptide

  Baseline, Week 17

Study Arms (1)

Enzalutamide

EXPERIMENTAL

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

Interventions

Enzalutamide DRUG

Also known as: MDV3100

Enzalutamide

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe concurrent disease
• Metastases in the brain

Sponsors & Collaborators

• Pfizer: lead
• Astellas Pharma Inc: collaborator
• Medivation LLC, a wholly owned subsidiary of Pfizer Inc.: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77303, United States

Location

Related Publications (1)

• Efstathiou E, Titus M, Wen S, Hoang A, Karlou M, Ashe R, Tu SM, Aparicio A, Troncoso P, Mohler J, Logothetis CJ. Molecular characterization of enzalutamide-treated bone metastatic castration-resistant prostate cancer. Eur Urol. 2015 Jan;67(1):53-60. doi: 10.1016/j.eururo.2014.05.005. Epub 2014 May 29.

  PMID: 24882673 DERIVED

MeSH Terms

Interventions

enzalutamide

Results Point of Contact

• Title: Mohammad Hirmand, MD, VP, Clinical Development
• Organization: Medivation, Inc.

mohammad.hirmand@medivation.com

415-829-4126

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

• Medical Monitor

  Medivation, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 23, 2010
• Study Start: February 18, 2010
• Primary Completion: February 29, 2012
• Study Completion: August 31, 2013
• Last Updated: October 23, 2018
• Results First Posted: November 17, 2014

Record last verified: 2018-10

Locations

US (1)