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

Metastatic Progressive Castration-resistant Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091103
• Other study ID #: CRPC-MDA-1
• Secondary ID: C3431017
• Status: Completed
• Phase: Phase 2
• Start date: February 18, 2010
• Est. completion date: August 31, 2013

Study information

• Verified date: October 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2013
• Est. primary completion date: February 29, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Progressive Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Enzalutamide

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Pfizer	Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)	Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.	Baseline, Week 9
Secondary	Median Time to Study Drug Discontinuation	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.	Duration of study treatment through the data cutoff, up to 3 years.
Secondary	Change From Baseline in Urinary N-Telopeptide	Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5.	Baseline, Week 5
Secondary	Change From Baseline in Urinary N-Telopeptide	Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9.	Baseline, Week 9
Secondary	Change From Baseline in Urinary N-Telopeptide	Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17.	Baseline, Week 17
Secondary	Change From Baseline in Urinary N-Telopeptide	Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25.	Baseline, Week 25
Secondary	Change From Baseline in Urinary N-Telopeptide		Baseline, Week 33
Secondary	Change From Baseline in Urinary N-Telopeptide	Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41.	Baseline, Week 41
Secondary	Change From Baseline in Urinary N-Telopeptide	Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49.	Baseline, Week 49
Secondary	Change From Baseline in Urinary N-Telopeptide	Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57.	Baseline, Week 57
Secondary	Change From Baseline in Urinary N-Telopeptide	Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.	Baseline, Week 65