Safety and Efficacy of CC-4047 in Subjects With Metastatic Hormone Refractory Prostate Cancer (HRPC)

December 18, 2006 updated by: Celgene Corporation

Phase II Randomized Open-Label, Two-Arm Study of Safety and Efficacy of CC-4047 in Subjects With Metastatic Hormone Refractory Prostate Cancer (HRPC)

Phase II randomized open-label, two-arm study of safety and efficacy of CC-4047 in subjects with metastatic hormone refractory prostate cancer (HRPC)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220-3706
        • University of Colorado Health Science Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

November 7, 2003

First Submitted That Met QC Criteria

November 12, 2003

First Posted (Estimate)

November 13, 2003

Study Record Updates

Last Update Posted (Estimate)

December 19, 2006

Last Update Submitted That Met QC Criteria

December 18, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-4047-PC-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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