A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer
This study has been completed.
Sponsor:
Centocor, Inc.
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00401765
First received: November 17, 2006
Last updated: April 7, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Neoplasms |
Drug: CNTO 328 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) Combined With Docetaxel in Subjects With Metastatic Hormone-Refractory Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Centocor, Inc.:
Primary Outcome Measures:
- Assess the safety and tolerability of multiple dosing regimens of CNTO328 when administered in combination with docetaxel each cycle. The pharmacokinetics of docetaxel when administered alone and in combination with CNTO328 will be assessed.
Secondary Outcome Measures:
- To evaluate efficacy and pharmacodynamics of CNTO328 administered in combination with docetaxel each cycle. In a limited number of patients, the pharmacokinetics of CNTO328 alone and in combination with docetaxel will also be evaluated.
| Enrollment: | 40 |
| Study Start Date: | October 2005 |
| Study Completion Date: | November 2009 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Radiologically documented metastatic disease
- No prior systemic chemotherapy for metastatic HRPC
- 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 PSA values obtained at least 7 days apart or Radionucleotide bone scan progression
- Karnofsky performance status of >=60
Exclusion Criteria:
- Prostate cancer that does not express serum PSA or is < 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 >= 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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00401765 History of Changes |
| Other Study ID Numbers: | CR005275 |
| Study First Received: | November 17, 2006 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Centocor, Inc.:
|
Prostatic neoplasm intravenous docetaxel monoclonal antibody |
Additional relevant MeSH terms:
|
Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013