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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
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: February 8, 2012
Last updated: September 12, 2017
Last verified: September 2017
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: Masking: None (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 Pfizer:

Primary Outcome Measures:
  • To assess the safety and tolerability of MDV3100 in combination with Docetaxel [ Time Frame: 30 days ]

    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 ]
    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: 23
Actual Study Start Date: January 24, 2012
Estimated Study Completion Date: December 31, 2017
Primary Completion Date: July 1, 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)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
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
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Please refer to this study by its identifier: NCT01565928

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Astellas Pharma Inc
Medivation, Inc.
Study Director: Pfizer Pfizer Call Center Pfizer
  More Information

Responsible Party: Pfizer Identifier: NCT01565928     History of Changes
Other Study ID Numbers: MDV3100-06
C3431002 ( Other Identifier: Alias Study Number )
Study First Received: February 8, 2012
Last Updated: September 12, 2017

Keywords provided by Pfizer:
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 September 19, 2017