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)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Urogenital Diseases
+7

+ Genital Diseases
+ Genital Diseases, Male
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorCelgene Corporation
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual 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) 
NCT00072722
Principal SponsorCelgene Corporation
Last updated: January 14, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Genital Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Prostatic Neoplasms
Urogenital Neoplasms
Male Urogenital Diseases
Criteria

Inclusion Criteria: * 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 * 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. * Antiandrogen therapy must have been stopped at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to entering study with evidence of a rising PSA (from baseline) measured x 2 at least 2 weeks apart Testicular androgen suppression must be maintained with either LHRH therapy of bilateral orchiectomy. * Must use barrier contraception (latex condom) when engaging in reproductive activity with women of child-bearing potential throughout the course of study treatment and for 4 weeks following the discontinuation of study treatment. * May have had only one prior regimen of chemotherapy for prostate cancer. The chemotherapy must have been stopped at least 4 weeks prior to study entry. * Disease-free of other malignancies for greater than 5 years with the exception of curatively treated basal cell, squamous cell carcinoma of the skin of Ta transitional cell carcinoma of the bladder. * ECOG performance status of 0 or 1. * Serum creatinine greater than or equal to 2.0 mg% * Adequate hematologic functions: Granulocytes greater than or equal to 1800 mm3 and platelets greater than or equal to 100,000 mm3. * Adequate hepatocellular function: AST\<2 x normal and bilirubin\<1.5mg/dl * No active unresolved infection Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study. * Use of any other experimental drug or therapy within 28 days of baseline. * Any prior use of CC-4047 of Thalidomide * Tumors containing small cell or sarcomatoid elements * Symptomatic bone metastases. * 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. * Non-PSA producing tumors

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 CenterDenver, United StatesSee the location
Suspended
Baylor College of MedicineHouston, United States
Completed2 Study Centers