Clinical trial NCT00638378: Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
Official title: A Phase 2, Open-Label Study of INCB018424 Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 2.
* 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.

Primary outcomes:
measure: Number of Participants With a Prostate-specific Antigen Response
timeFrame: Assessed monthly from Baseline until the end of study (up to 8 months)
measure: Number of Participants With Adverse Events (AE)
timeFrame: From Baseline through to the end of study (up to 8 months)
Secondary outcomes:
measure: Time to Progression
timeFrame: From Baseline until the end of study (up to 8 months).
measure: Number of Participants With a Complete Response or Partial Response
timeFrame: From Baseline through the end of study (up to 8 months)
Other outcomes:
Locations:
city: Highland
country: United States
state: California
city: Montebello
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Galesburg
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Grand Rapids
country: United States
state: Michigan
city: Jefferson City
country: United States
state: Missouri
city: Great Falls
country: United States
state: Montana
city: Cherry Hill
country: United States
state: New Jersey
city: Staten Island
country: United States
state: New York
city: Bismarck
country: United States
state: North Dakota
city: Bethlehem
country: United States
state: Pennsylvania
city: Sumter
country: United States
state: South Carolina
city: Lacey
country: United States
state: Washington
Study officials:
References: