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Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer

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NCT01565928

Last updated on April 19, 2018
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FOR MORE INFORMATION
Study Location
Memorial Sloan Kettering Cancer Center
New York, New York, 10065 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- Willing and able to provide informed consent;

- Men, 18 years of age or older;

- Histologically or cytologically confirmed adenocarcinoma of the prostate;

- 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;

- Known or suspected brain metastasis;

- History of another malignancy within the previous 5 years;

- Prior treatment with docetaxel-based chemotherapy

NCT01565928
Pfizer
Completed
Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer

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Pfizer Clinical Trials Contact Center

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[email protected]

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Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
A Phase 1b, Open-label, Safety And Tolerability Study Of Oral Mdv3100 In Combination With Docetaxel In Men With Advanced Prostate Cancer
The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: MDV3100
4 x 40 mg capsules, orally, once per day
Experimental: MDV3100
Intervention: Drug: MDV3100
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
23
October 2017
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing and able to provide informed consent;
  • Men, 18 years of age or older;
  • Histologically or cytologically confirmed adenocarcinoma of the prostate;
  • Ongoing androgen deprivation therapy

Exclusion Criteria:

  • Severe concurrent disease;
  • Known or suspected brain metastasis;
  • History of another malignancy within the previous 5 years;
  • Prior treatment with docetaxel-based chemotherapy
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
 
 
NCT01565928
MDV3100-06
C3431002 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
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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