A Phase 2, Open-Label Study of INCB018424 Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Ruxolitinib
- Conditions
- Prostate Cancer
- Sponsor
- Incyte Corporation
- Enrollment
- 22
- Primary Endpoint
- Number of Participants With a Prostate-specific Antigen Response
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Baseline serum PSA level of ≥ 10 ng/mL
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Ruxolitinib
Outcomes
Primary Outcomes
Number of Participants With a Prostate-specific Antigen Response
Time Frame: 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)
Time Frame: 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 Outcomes
- Time to Progression(From Baseline until the end of study (up to 8 months).)
- Number of Participants With a Complete Response or Partial Response(From Baseline through the end of study (up to 8 months))