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

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NCT01091103

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
MD Anderson Cancer Center
Houston, Texas, 77303 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Progressive Castration-resistant Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Confirmed prostate cancer

- Presence of metastatic disease to the bone

- Ongoing androgen deprivation therapy

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Severe concurrent disease

- Metastases in the brain

NCT01091103
Pfizer
Completed
Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide

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Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide
A Study Of Continuous Oral Dosing Of A Novel Antiandrogen Mdv3100, In Castration-resistant Bone Metastatic Prostate Cancer Patients Evaluating The Tumor Micro-enviroment
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.
Not Provided
Interventional
Phase 2
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Progressive Castration-resistant Prostate Cancer
Drug: Enzalutamide
Other Name: MDV3100
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.
Intervention: Drug: Enzalutamide
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 31, 2013
February 29, 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01091103
CRPC-MDA-1
C3431017 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Medical Monitor Medivation, Inc.
Pfizer
August 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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