This is a clinical trial of orally administered Ruxolitinib (INCB018424) in patients whose disease has progressed following 1 prior chemotherapy regimen (not including anti-androgens or ketoconazole) for metastatic, androgen-independent prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Ruxolitinib 25 mg tablets taken with water twice a day.
Unnamed facility
Highland, California, United States
Unnamed facility
Montebello, California, United States
Unnamed facility
Mountain View, California, United States
Number of Participants With a Prostate-specific Antigen Response
A prostate-specific antigen (PSA) response was defined as a PSA decline from Baseline of 50% or greater, repeated on 2 occasions at least 4 weeks apart.
Time frame: Assessed monthly from Baseline until the end of study (up to 8 months)
Number of Participants With Adverse Events (AE)
A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 3.0: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
Time frame: From Baseline through to the end of study (up to 8 months)
Time to Progression
The time from first dosing day to the date of disease progression: * Progressive measurable disease by RECIST criteria (regardless of bone scan or prostate-specific antigen (PSA) results). * Development of unequivocal new lesions on bone scan without clinical suspicion of a "flare" reaction. * In patients who responded or had a decreased PSA from Baseline, a rise of 50% from PSA nadir, if the increase is ≥ 5 ng/mL or back to Baseline and confirmed by a 2nd value. * In patients with no decrease in PSA from Baseline, a 25% rise over Baseline and ≥ 5 ng/mL confirmed by a 2nd value.
Time frame: From Baseline until the end of study (up to 8 months).
Number of Participants With a Complete Response or Partial Response
Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits.
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Unnamed facility
Galesburg, Illinois, United States
Unnamed facility
Overland Park, Kansas, United States
Unnamed facility
Wichita, Kansas, United States
Unnamed facility
Grand Rapids, Michigan, United States
Unnamed facility
Jefferson City, Missouri, United States
Unnamed facility
Great Falls, Montana, United States
Unnamed facility
Cherry Hill, New Jersey, United States
...and 5 more locations
Time frame: From Baseline through the end of study (up to 8 months)