Completed
A PHASE 1B, OPEN-LABEL, SAFETY AND TOLERABILITY STUDY OF ORAL MDV3100 IN COMBINATION WITH DOCETAXEL IN MEN WITH ADVANCED PROSTATE CANCER
What is being tested
MDV3100
Drug
Who is being recruted
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Over 18 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: January 2012
Summary
Principal SponsorPfizer
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 24, 2012
Actual date on which the first participant was enrolled.The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.
Official TitleA PHASE 1B, OPEN-LABEL, SAFETY AND TOLERABILITY STUDY OF ORAL MDV3100 IN COMBINATION WITH DOCETAXEL IN MEN WITH ADVANCED PROSTATE CANCER
Principal SponsorPfizer
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
23 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases
Criteria
4 inclusion criteria required to participate
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
4 exclusion criteria prevent from participating
Severe concurrent disease;
Known or suspected brain metastasis;
History of another malignancy within the previous 5 years;
Prior treatment with docetaxel-based chemotherapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Suspended
Memorial Sloan Kettering Cancer Center
New York, United StatesOpen Memorial Sloan Kettering Cancer Center in Google MapsSuspended
Memorial Sloan-Kettering Cancer Center
New York, United StatesSuspended
Virginia Oncology Associates
Norfolk, United StatesCompleted3 Study Centers