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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00638378
• Other study ID #: INCB 18424-254
• Status: Terminated
• Phase: Phase 2
• First received: March 12, 2008
• Last updated: January 15, 2018
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2018
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Ruxolitinib
Ruxolitinib 25 mg tablets taken with water twice a day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Time to Progression	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.	From Baseline until the end of study (up to 8 months).
Secondary	Number of Participants With a Complete Response or Partial Response	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.	From Baseline through the end of study (up to 8 months)