Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00638378

Run by

Incyte Corporation

People needed

22

Starts

2008-02-01

Expected to finish

2009-01-01

Last updated by the study team

2018-02-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Highland, California, United States
• Study site — Montebello, California, United States
• Study site — Mountain View, California, United States
• Study site — Galesburg, Illinois, United States
• Study site — Overland Park, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Jefferson City, Missouri, United States
• Study site — Great Falls, Montana, United States
• Study site — Cherry Hill, New Jersey, United States
• Study site — Staten Island, New York, United States
• Study site — Bismarck, North Dakota, United States
• Study site — Bethlehem, Pennsylvania, United States
• Study site — Sumter, South Carolina, United States
• Study site — Lacey, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.