Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
NCT ID: NCT00638378
Last Updated: 2018-02-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
22 participants
INTERVENTIONAL
2008-02-29
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Ruxolitinib
Ruxolitinib 25 mg tablets taken with water twice a day.
Interventions
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Ruxolitinib
Ruxolitinib 25 mg tablets taken with water twice a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Locations
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Highland, California, United States
Montebello, California, United States
Mountain View, California, United States
Galesburg, Illinois, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Grand Rapids, Michigan, United States
Jefferson City, Missouri, United States
Great Falls, Montana, United States
Cherry Hill, New Jersey, United States
Staten Island, New York, United States
Bismarck, North Dakota, United States
Bethlehem, Pennsylvania, United States
Sumter, South Carolina, United States
Lacey, Washington, United States
Countries
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Other Identifiers
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INCB 18424-254
Identifier Type: -
Identifier Source: org_study_id
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