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A Phase 2, Open-Label Study of INCB018424 Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Prostate Cancer

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Trial Information

A Phase 2, Open-Label Study of INCB018424 Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer

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,

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With a Prostate-specific Antigen Response

Outcome Description:

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.

Outcome Time Frame:

Assessed monthly from Baseline until the end of study (up to 8 months)

Safety Issue:



United States: Food and Drug Administration

Study ID:

INCB 18424-254



Start Date:

February 2008

Completion Date:

January 2009

Related Keywords:

  • Metastatic Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms



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