Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
This study has been terminated.
(According to the protocol, the sponsor terminated the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response.)
Sponsor:
Incyte Corporation
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00638378
First received: March 12, 2008
Last updated: January 20, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 2 |
| 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:
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 May 21, 2013