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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.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01565928
First received: February 8, 2012
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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 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


Estimated Enrollment: 18
Study Start Date: February 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDV3100 Drug: MDV3100
4 x 40 mg capsules, orally, once per day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565928

Locations
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
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01565928     History of Changes
Other Study ID Numbers: MDV3100-06
Study First Received: February 8, 2012
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
Prostate cancer
docetaxel
MDV3100

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013