Completed
Phase II Randomized Open-Label, Two-Arm Study of Safety and Efficacy of CC-4047 in Subjects With Metastatic Hormone Refractory Prostate Cancer (HRPC)
What is being tested
Data Collection
Who is being recruted
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Over 18 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: September 2003
Summary
Principal SponsorCelgene Corporation
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.Phase II randomized open-label, two-arm study of safety and efficacy of CC-4047 in subjects with metastatic hormone refractory prostate cancer (HRPC)
Official TitlePhase II Randomized Open-Label, Two-Arm Study of Safety and Efficacy of CC-4047 in Subjects With Metastatic Hormone Refractory Prostate Cancer (HRPC)
Principal SponsorCelgene Corporation
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
36 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
13 inclusion criteria required to participate
Histologically confirmed adenocarcinoma of the prostate with radiographic evidence of metastases and PSA progression following hormonal therapy for metastatic disease. Subjects must have evidence of progression of disease as demonstrated by 2 consecutive rises in PSA (an absolute change of at least 1ng/ml) separated by at least 28 days.
Understand and voluntarily sign an informed consent form
Adult male subjects, age 18 or older at the time of signing the informed consent form
Able to adhere to the study visit schedule and other protocol requirements
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9 exclusion criteria prevent from participating
Symptomatic bone metastases.
Non-PSA producing tumors
Concurrent use of any other anti-cancer agents.
Known brain disease that is symptomatic, is currently being treated with corticosteroids, or has not been previously irradiated.
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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 2 locations
Suspended
University of Colorado Health Science Center
Denver, United StatesOpen University of Colorado Health Science Center in Google MapsSuspended
Baylor College of Medicine
Houston, United StatesCompleted2 Study Centers