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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
N/A
Not Enrolling
Male
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,
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.

Type of Study:

Interventional

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:

No

Authority:

United States: Food and Drug Administration

Study ID:

INCB 18424-254

NCT ID:

NCT00638378

Start Date:

February 2008

Completion Date:

January 2009

Related Keywords:

  • Metastatic Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Hinsdale, Illinois  60521
Great Falls, Montana  59405
Fountain Valley, California  92708
Columbia, Missouri  65203
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Seattle, Washington  98195
Flint, Michigan  48532
Kansas City, Kansas  66160
Hackensack, New Jersey  07601
Charleston, South Carolina  
Bismarck, North Dakota  58501