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Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

- Men with metastatic castration-resistant prostate cancer

- Progressive disease on androgen deprivation therapy

- Patients must agree to continue androgen deprivation therapy with a GnRH
agonist/antagonist throughout the study or have had a prior bilateral orchiectomy

- ECOG performance score ≤ 1

- Estimated life expectancy of ≥ 12 months

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

- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or
enzalutamide for the treatment of prostate cancer

- Prior participation in a clinical trial of an investigational agent that inhibits the
androgen receptor or androgen synthesis (unless the treatment was placebo)

- History of brain metastasis, active leptomeningeal disease or seizure

- Severe cardiovascular or hepatic disease

- Pituitary or adrenal dysfunction

NCT01995513
Pfizer
Active, not recruiting
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

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[email protected]

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A Phase 4, Randomized, Double-blind, Placebo-controlled Study Of Continued Enzalutamide Treatment Beyond Progression In Patients With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
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Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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    160 mg by mouth once daily
    Other Names:
    • MDV3100
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  • Drug: Abiraterone
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  • Drug: Placebo for Enzalutamide
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  • Drug: Prednisone
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  • Experimental: Enzalutamide & Abiraterone/prednisone
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    Interventions:
    • Drug: Enzalutamide
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  • Active Comparator: Enzalutamide placebo & Abiraterone/prednisone
    Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily.
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Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
509
December 2017
November 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men with metastatic castration-resistant prostate cancer
  • Progressive disease on androgen deprivation therapy
  • Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
  • ECOG performance score ? 1
  • Estimated life expectancy of ? 12 months

Exclusion Criteria:

  • Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer
  • Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
  • History of brain metastasis, active leptomeningeal disease or seizure
  • Severe cardiovascular or hepatic disease
  • Pituitary or adrenal dysfunction
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
Australia,   Belgium,   Denmark,   Finland,   France,   Italy,   Slovakia,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT01995513
MDV3100-10
2013-000722-54 ( EudraCT Number )
C3431013 ( 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 Director Medviation, Inc.
Pfizer
October 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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