An Open-Label, Multicenter, Phase 2 Study of Single-Agent CNTO 888 (an Anti-CCL2 Monoclonal Antibody) for the Treatment of Subjects With Metastatic Castrate-Resistant Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
An Open-Label, Multicenter, Phase 2 Study of Single-Agent CNTO 888 (an Anti-CCL2 Monoclonal Antibody) for the Treatment of Subjects With Metastatic Castrate-Resistant Prostate Cancer
This is an open-label (all people know the identity of the intervention), multicenter trial
(conducted in more than one center) in participants with metastatic castrate-resistant
prostate cancer. The trial consists of 3 phases: screening period, treatment period of
approximately 4 months, and a follow-up period (Week 1, 4, 8 and 12 after the last dose) of
up to 12 weeks after the administration of last dose. The participants will receive carlumab
at the dose of 15 milligram/kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid
or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute
period once every 2 weeks until disease progression. Efficacy of the participants will be
primarily evaluated by composite response. Participants' safety will be monitored throughout
the study.
Inclusion Criteria:
- Histological documentation of adenocarcinoma of the prostate
- Received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens
and had disease progression following the last therapy
- Serum prostate specific antigen (PSA) greater than or equal to 5.0
nanogram/milliliter (ng/ml) within 4 weeks prior to the first dose of study agent
- Orchiectomy (surgery to remove one or both testicles) or testosterone less than 50
nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks
prior to the first dose of study agent
- At least 6 weeks from prior docetaxel chemotherapy regimen to first dose
of study agent
Exclusion Criteria:
- Experience a hormonal treatment withdrawal response (including a lowering of PSA that
was previously rising or symptomatic improvement)
- Known or symptomatic Central Nervous System metastases
- Residual toxicities resulting from previous therapy that are Grade 2 or more (except
for alopecia)
- Known allergies, hypersensitivity, or intolerance to carlumab or its excipients or
clinically significant reactions to chimeric or human proteins
- Vaccinated with live, attenuated vaccines within 4 weeks prior to the
first dose of study agent
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants With Composite Response
Outcome Description:
The composite response is measured by change from Baseline in skeletal lesions, extra-skeletal lesions, and prostate specific antigen (PSA) values. A participant is considered to have composite response, if 1 of the following responses occurs after the first dose of carlumab: (1) Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST), (2) PSA response at 12 weeks and absence of skeletal and extra-skeletal progression or (3) Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression.
Outcome Time Frame:
Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
Safety Issue:
No
Principal Investigator
Centocor Research & Development, Inc., PA, USA Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Centocor Research & Development, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
CR015907
NCT ID:
NCT00992186
Start Date:
September 2009
Completion Date:
July 2011
Related Keywords:
- Prostate Cancer
- Prostate cancer
- Infusion
- Carlumab
- CNTO 888
- Prostatic Neoplasms
Name | Location |
|---|---|
| Miami, Florida 33176 | |
| Flint, Michigan 48532 | |
| Charleston, South Carolina |
