Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06616155 | Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer | PHASE1 | RECRUITING | 20 | — | — | Jun 1, 2026 | Jun 1, 2030 | May 5, 2026 | 3 | United States |
DLT will be defined based on the rate of drug-related grade 3-5 adverse events (AEs) experienced. AEs will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The proportion of patients at each dose level experiencing each grade level of toxicity will be described. To estimate the frequency and severity of AEs associated with treatment, the proportion of subjects encountering toxicity at each dose level will be reported with exact 95% binomial confidence intervals.
MTD will be defined based on the rate of drug-related grade 3-5 adverse events (AEs) experienced. MTD will be the highest dose level at which the probability of a subject experiencing a DLT during cycle 1 falls between 0.23 and 0.33.
| Arm | Type | Description |
|---|---|---|
| Treatment (ruxolitinib, enzalutamide) | EXPERIMENTAL | Patients receive ruxolitinib PO BID and enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, CT and bone scan throughout the study. Patients may also undergo a tissue biopsy on study. |
| Name | Type | Description |
|---|---|---|
| Biopsy | PROCEDURE | Undergo tissue biopsy |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Scan | PROCEDURE | Undergo bone scan |
| Computed Tomography | PROCEDURE | Undergo CT |
| Enzalutamide | DRUG | Given PO |
| Ruxolitinib | DRUG | Given PO |
Inclusion Criteria: * Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration * Males age ≥ 18 years with progressive metastatic, castration-resistant prostate cancer, previous adenocarci...