Study of INCB018424 Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
Information source: Incyte Corporation
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Prostate Cancer
Intervention: INCB018424 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Incyte Corporation Overall contact:
William M. Garrett, MBA, Phone: 302-498-6987, Email: wgarrett@incyte.com
Summary
This is a clinical trial of orally administered INCB018424 in patients whose disease has
progressed following 1 prior chemotherapy regimen (not including anti-androgens or
ketoconazole) for metastatic, androgen-independent prostate cancer.
Clinical Details
Official title: A Phase 2, Open-Label Study of INCB018424 Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
Study design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: PSA50 response rate of oral INCB018424 as monotherapy in the treatment of metastatic, androgen-independent prostate cancer and safety and tolerability of oral INCB018424 in patients with metastatic prostate cancer
Secondary outcome: Median time to progression in patients with metastatic androgen-independent prostate cancer and response rate according to RECIST criteria in patients with measurable metastatic prostate cancer who are treated with INCB018424.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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 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 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.
Locations and Contacts
William M. Garrett, MBA, Phone: 302-498-6987, Email: wgarrett@incyte.com
Highland, California, United States; Recruiting
Montebello, California, United States; Recruiting
Mountain View, California, United States; Recruiting
Galesburg, Illinois, United States; Recruiting
Overland Park, Kansas, United States; Recruiting
Wichita, Kansas, United States; Recruiting
Grand Rapids, Michigan, United States; Recruiting
Jefferson City, Missouri, United States; Recruiting
Great Falls, Montana 59405, United States; Recruiting
Cherry Hill, New Jersey, United States; Recruiting
Staten Island, New York, United States; Recruiting
Bismarck, North Dakota, United States; Recruiting
Bethlehem, Pennsylvania, United States; Recruiting
Sumter, South Carolina, United States; Recruiting
Lacey, Washington, United States; Recruiting
Additional Information
Starting date: February 2008
Ending date: April 2009
Last updated: July 3, 2008
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