Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

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.

Ruxolitinib 25 mg tablets taken with water twice a day.

Ruxolitinib

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.

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

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

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.

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).

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.

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.

Incyte Corporation

Age, Continuous

Sex: Female, Male

Study Director

The Intent-to-treat population, which included all patients enrolled in the study who took at least 1 dose of study medication.

Number of Participants With a Prostate-specific Antigen Response

According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of median time to progression was not assessed.

Time to Progression

Any adverse event

Treatment-related adverse event

Serious adverse event

Grade 3 or 4 adverse event

Discontinued study medication due to adverse event

Discontinued study due to adverse events

The Safety population included all enrolled patients who received at least 1 dose of study medication.

Number of Participants With Adverse Events (AE)

According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of tumor response rate was not assessed.

Spots Global Cancer Trial Database for Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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