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

This study is ongoing, but not recruiting participants.
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc. Identifier:
First received: February 8, 2012
Last updated: April 13, 2016
Last verified: April 2016
The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.

Condition Intervention Phase
Prostate Cancer
Drug: MDV3100
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-label, Safety and Tolerability Study of Oral MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • To assess the safety and tolerability of MDV3100 in combination with Docetaxel [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    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.

Secondary Outcome Measures:
  • To assess the pharmacokinetic (PK) parameters of docetaxel with and without concomitant MDV3100 treatment [ Time Frame: Day 1 of each treatment cycle with docetaxel ] [ Designated as safety issue: No ]
    Maximum plasma concentration (Cmax), area under the plasma concentration time profile from time zero extrapolated to last sample (AUC0-t), area under the plasma concentration time profile from time zero extrapolated to infinite time (AUC0-inf), and additional PK parameters, as data permit, of docetaxel, with and without concomitant administration of MDV3100

Enrollment: 22
Study Start Date: February 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDV3100 Drug: MDV3100
4 x 40 mg capsules, orally, once per day


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01565928

United States, New York
New York, New York, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
Study Director: Medical Director Medivation, Inc.
  More Information

Responsible Party: Medivation, Inc. Identifier: NCT01565928     History of Changes
Other Study ID Numbers: MDV3100-06 
Study First Received: February 8, 2012
Last Updated: April 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016