A Phase 1b, Open-label, Safety and Tolerability Study of Oral MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Phase 1b, Open-label, Safety and Tolerability Study of Oral MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the safety and tolerability of MDV3100 in combination with Docetaxel
Outcome Description:
The primary criteria for the evaluation of safety and tolerability are: The percentage of patients who require dose reduction of docetaxel and/or MDV3100 following Treatment Periods 1 and 2; The percentage of patients who discontinue docetaxel or MDV3100 due to an adverse event.
Outcome Time Frame:
30 days
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
MDV3100-06
NCT ID:
NCT01565928
Start Date:
February 2012
Completion Date:
April 2014
Related Keywords:
- Prostate Cancer
- Prostate cancer
- docetaxel
- MDV3100
- Prostatic Neoplasms
Name | Location |
|---|---|
| Albany, New York 12208 | |
| McLean, Virginia 22101 |
