Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
NCT01565928
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- 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
- Severe concurrent disease;
- Known or suspected brain metastasis;
- History of another malignancy within the previous 5 years;
- Prior treatment with docetaxel-based chemotherapy
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Descriptive Information | |||||
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Brief Title ICMJE | Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer | ||||
Official Title ICMJE | A PHASE 1B, OPEN-LABEL, SAFETY AND TOLERABILITY STUDY OF ORAL MDV3100 IN COMBINATION WITH DOCETAXEL IN MEN WITH ADVANCED PROSTATE CANCER | ||||
Brief Summary | The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE | Drug: MDV3100
4 x 40 mg capsules, orally, once per day | ||||
Study Arms ICMJE | Experimental: MDV3100
Intervention: Drug: MDV3100 | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 23 | ||||
Original Estimated Enrollment ICMJE | 18 | ||||
Actual Study Completion Date ICMJE | February 26, 2018 | ||||
Actual Primary Completion Date | July 1, 2013 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01565928 | ||||
Other Study ID Numbers ICMJE | MDV3100-06 C3431002 ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | January 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |