Status:
COMPLETED
A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer
Lead Sponsor:
Centocor, Inc.
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of docetaxel and CNTO 328 when given together as a treatment. The second goal of this study is to determine if a combination of docetaxel and CNTO ...
Detailed Description
This is a Phase 1 open-label, multicenter, nonrandomized study of the safety and pharmacokinetics of the combination of CNTO 328 and docetaxel in patients with metastatic Hormone-Refractory Prostate C...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Radiologically documented metastatic disease
- No prior systemic chemotherapy for metastatic hormone refractory prostate cancer
- Progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or anti-androgen treatment within 12 months of screening based on 1 of the following: Transaxial imaging tumor progression, Rise in 2 consecutive prostate-specifec antigen (PSA) values obtained at least 7 days apart or Radionucleotide bone scan progression
- Karnofsky performance status of greater than or equal to 60
Exclusion
- Prostate cancer that does not express serum PSA or is less than 5.0 ng/mL at screening
- Received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer
- Prior malignancy (other than prostate cancer) except adequately treated basal cell or squamous cell carcinoma of the skin or other cancer for which the subject has been disease-free for greater than or equal to 3 years
- Known central nervous system metastases
- Received any over-the-counter or herbal treatment for prostate cancer (eg, PC SPES \[an herbal refined powder\]) within 4 weeks prior to screening.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00401765
Start Date
September 1 2005
End Date
November 1 2009
Last Update
May 26 2014
Active Locations (5)
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1
Baltimore, Maryland, United States
2
New York, New York, United States
3
Chapel Hill, North Carolina, United States
4
Philadelphia, Pennsylvania, United States