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

NCT00638378 | Terminated Phase 2 Results

• 1 other identifier: INCB 18424-254
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With a Prostate-specific Antigen Response

  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.

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

• Number of Participants With Adverse Events (AE)

  A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 3.0: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).

  From Baseline through to the end of study (up to 8 months)

Secondary Outcomes (2)

• Time to Progression

  From Baseline until the end of study (up to 8 months).

• Number of Participants With a Complete Response or Partial Response

  From Baseline through the end of study (up to 8 months)

Study Arms (1)

Ruxolitinib

EXPERIMENTAL

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.

Drug: Ruxolitinib

Interventions

Ruxolitinib DRUG

Ruxolitinib 25 mg tablets taken with water twice a day.

Also known as: INCB018424

Ruxolitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (15)

Unknown Facility

Highland, California, United States

Location

Unknown Facility

Montebello, California, United States

Location

Unknown Facility

Mountain View, California, United States

Location

Unknown Facility

Galesburg, Illinois, United States

Location

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Wichita, Kansas, United States

Location

Unknown Facility

Grand Rapids, Michigan, United States

Location

Unknown Facility

Jefferson City, Missouri, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Cherry Hill, New Jersey, United States

Location

Unknown Facility

Staten Island, New York, United States

Location

Unknown Facility

Bismarck, North Dakota, United States

Location

Unknown Facility

Bethlehem, Pennsylvania, United States

Location

Unknown Facility

Sumter, South Carolina, United States

Location

Unknown Facility

Lacey, Washington, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 12, 2018
• Results First Posted: January 20, 2012

Record last verified: 2018-01

Locations

US (15)