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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01565928
Recruitment Status : Active, not recruiting
First Posted : March 29, 2012
Last Update Posted : January 3, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: MDV3100 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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
Actual Study Start Date : January 2012
Primary Completion Date : July 2013
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MDV3100 Drug: MDV3100
4 x 40 mg capsules, orally, once per day


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565928


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
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
Pfizer
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01565928     History of Changes
Other Study ID Numbers: MDV3100-06
C3431002 ( Other Identifier: Alias Study Number )
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Keywords provided by Pfizer:
Prostate cancer
docetaxel
MDV3100
enzalutamide
Xtandi

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action