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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
Open (Enrolling)
Male
Prostate Cancer

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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