A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human av Integrins (CNTO 95) in Combination With Docetaxel for the First-Line Treatment of Subjects With Metastatic Hormone Refractory Prostate Cancer
This is a multicenter (when more than one hospital or medical school team work on a medical
research study), randomized (the study drug is assigned by chance), double-blind (neither
physician nor participant knows the treatment that the participant receives) study of
intetumumab in combination with docetaxel and prednisone for the first-line treatment of
participants with metastatic hormone-refractory prostate cancer. There will be 2 study
groups. One group will receive intetumumab in combination with docetaxel and prednisone
(study treatment) and the other group will receive placebo (an inactive substance that is
compared with a drug to test whether the drug has a real effect in a clinical trial)
matching to intetumumab in combination with docetaxel and prednisone (control treatment).
The duration of treatment will be 6 months. Participants who respond to treatment with
stable disease or better will receive extended treatment until disease progression (disease
worsening) or for an additional 6 months, whichever occurs first. Treatment can be further
continued with the sponsor's discretion after receiving 6 months of extended treatment, if
participant response to the treatment (with stable disease, partial response, or complete
response). Participants who have confirmed progressive disease while receiving study
treatment may have their treatment unblinded (participants will know the name of drug which
was given to them), if they wish to be considered for alternative treatment. Participants
who were receiving the control treatment will be considered to have completed the study
treatment, and will have the option to receive alternative treatment. Alternative treatment
will either be intetumumab along with docetaxel and prednisone or intetumumab alone.
Participants' safety will be monitored throughout the study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression-Free Survival (PFS)
The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Centocor, Inc. Clinical Trial
United States: Food and Drug Administration
|Birmingham, Alabama 35294|
|Fountain Valley, California 92708|
|Kansas City, Kansas 66160|
|Metairie, Louisiana 70006|
|Charleston, South Carolina|