Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
- Registration Number
- NCT00638378
- Lead Sponsor
- Incyte Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 22
- Diagnosed with radiographically-documented metastatic prostate cancer that has progressed while receiving androgen-suppressive therapy in the form of a bilateral orchiectomy or Gonadotropin-Releasing Hormone (GnRH) agonist (eg, leuprolide, goserelin).
- Patients must demonstrate evidence of progressive disease based on 1 of the following criteria: 1) Progressive measurable disease, or 2) Progressive rise in prostate-specific antigen (PSA) level (2 consecutive rises from a prior reference level), or 3) Development of new lesions on bone scan.
- If receiving a GnRH agonist as primary hormonal therapy, the serum testosterone level must be ≤ 50 ng/mL.
- Must have received and progressed during or following 1 prior chemotherapy regimen for metastatic disease (not including an anti-androgen or ketoconazole); or, must have discontinued prior systemic therapy because of poor tolerance or other adverse effects; or, must have refused chemotherapy treatment. Patients having undergone more than 1 prior chemotherapy regimen may be admitted at the discretion of the sponsor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Baseline serum PSA level of ≥ 10 ng/mL
- Received any anti-cancer medications in the 30 days before receiving their first dose of study medication except for GnRH agonists and bisphosphonates.
- Any unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ruxolitinib Ruxolitinib 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.
- Primary Outcome Measures
Name Time Method Number of Participants With a Prostate-specific Antigen Response Assessed monthly from Baseline until the end of study (up to 8 months) 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) From Baseline through to the end of study (up to 8 months) 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).
- Secondary Outcome Measures
Name Time Method Time to Progression From Baseline until the end of study (up to 8 months). 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 From Baseline through the end of study (up to 8 months) 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.