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

Sponsor:	Incyte Corporation
Information provided by (Responsible Party):	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00638378

Purpose

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.

Condition	Intervention	Phase
Metastatic Prostate Cancer	Drug: Ruxolitinib	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Open-Label Study of INCB018424 Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Number of Participants With a Prostate-specific Antigen Response [ Time Frame: Assessed monthly from Baseline until the end of study (up to 8 months) ] [ Designated as safety issue: No ]
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.
Number of Participants With Adverse Events (AE) [ Time Frame: From Baseline through to the end of study (up to 8 months) ] [ Designated as safety issue: No ]
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).

Secondary Outcome Measures:

Time to Progression [ Time Frame: From Baseline until the end of study (up to 8 months). ] [ Designated as safety issue: No ]
The time from first dosing day to the date of disease progression:
- Progressive measurable disease by RECIST criteria (regardless of bone scan or prostate-specific antigen (PSA) results).
- Development of unequivocal new lesions on bone scan without clinical suspicion of a "flare" reaction.
- In patients who responded or had a decreased PSA from Baseline, a rise of 50% from PSA nadir, if the increase is ≥ 5 ng/mL or back to Baseline and confirmed by a 2nd value.
- In patients with no decrease in PSA from Baseline, a 25% rise over Baseline and ≥ 5 ng/mL confirmed by a 2nd value.
Number of Participants With a Complete Response or Partial Response [ Time Frame: From Baseline through the end of study (up to 8 months) ] [ Designated as safety issue: No ]
Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits.

Enrollment:	22
Study Start Date:	February 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ruxolitinib 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 Ruxolitinib 25 mg tablets taken with water twice a day. Other Name: INCB018424

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638378

Locations

United States, California

Highland, California, United States

Montebello, California, United States

Mountain View, California, United States
United States, Illinois

Galesburg, Illinois, United States
United States, Kansas

Overland Park, Kansas, United States

Wichita, Kansas, United States
United States, Michigan

Grand Rapids, Michigan, United States
United States, Missouri

Jefferson City, Missouri, United States
United States, Montana

Great Falls, Montana, United States, 59405
United States, New Jersey

Cherry Hill, New Jersey, United States
United States, New York

Staten Island, New York, United States
United States, North Dakota

Bismarck, North Dakota, United States
United States, Pennsylvania

Bethlehem, Pennsylvania, United States
United States, South Carolina

Sumter, South Carolina, United States
United States, Washington

Lacey, Washington, United States

Sponsors and Collaborators

Incyte Corporation

More Information

No publications provided

Responsible Party:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00638378 History of Changes
Other Study ID Numbers:	INCB 18424-254
Study First Received:	March 12, 2008
Results First Received:	December 15, 2011
Last Updated:	January 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Incyte Corporation:

Prostate Cancer

Additional relevant MeSH terms:

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

Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012