A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer
Completed · Phase 1
Conditions studied: Prostatic Neoplasms
In brief
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 328 has an effect on prostate cancer.
Key facts
- Study ID
- NCT00401765
- Run by
- Centocor, Inc.
- People needed
- 40
- Starts
- 2005-09-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2014-05-26
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Study site — Baltimore, Maryland, United States
- Study site — New York, New York, United States
- Study site — Chapel Hill, North Carolina, United States
- Study site — Philadelphia, Pennsylvania, United States
- Study site — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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