Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2, Open-Label Study of INCB018424 Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer|
- Number of Participants With a Prostate-specific Antigen Response [ Time Frame: Assessed monthly from Baseline until the end of study (up to 8 months) ] [ Designated as safety issue: No ]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.
- Number of Participants With Adverse Events (AE) [ Time Frame: From Baseline through to the end of study (up to 8 months) ] [ Designated as safety issue: No ]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 to Progression [ Time Frame: From Baseline until the end of study (up to 8 months). ] [ Designated as safety issue: No ]
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.
- Number of Participants With a Complete Response or Partial Response [ Time Frame: From Baseline through the end of study (up to 8 months) ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
Ruxolitinib 25 mg tablets taken with water twice a day.
Other Name: INCB018424
|United States, California|
|Highland, California, United States|
|Montebello, California, United States|
|Mountain View, California, United States|
|United States, Illinois|
|Galesburg, Illinois, United States|
|United States, Kansas|
|Overland Park, Kansas, United States|
|Wichita, Kansas, United States|
|United States, Michigan|
|Grand Rapids, Michigan, United States|
|United States, Missouri|
|Jefferson City, Missouri, United States|
|United States, Montana|
|Great Falls, Montana, United States, 59405|
|United States, New Jersey|
|Cherry Hill, New Jersey, United States|
|United States, New York|
|Staten Island, New York, United States|
|United States, North Dakota|
|Bismarck, North Dakota, United States|
|United States, Pennsylvania|
|Bethlehem, Pennsylvania, United States|
|United States, South Carolina|
|Sumter, South Carolina, United States|
|United States, Washington|
|Lacey, Washington, United States|