Ruxolitinib and Enzalutamide for Metastatic Castration-Resistant Prostate Cancer
This study is testing a combination of two drugs, ruxolitinib and enzalutamide, for men with prostate cancer that has spread (metastatic) and is no longer responding to hormone therapy (castration-resistant). Ruxolitinib works by blocking proteins called JAK1 and JAK2, which can help slow tumor growth. Enzalutamide blocks male hormones (androgens) that prostate cancer cells often use to grow. The main goals are to find the safest dose and understand any side effects of this drug combination. We also want to see how well it works. You may be able to join if you are a man aged 18 or older with this type of prostate cancer. The study plans to enroll 20 patients.
- Study design
- This is a Phase I/II interventional study, meaning it focuses on safety and finding the best dose, and also looks at how well the treatment works. It plans to enroll 20 participants.
- What's involved
- You would undergo a tissue biopsy, blood sample collection, bone scan, and CT scan. You would also take enzalutamide by mouth.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for safety (dose-limiting toxicity and maximum tolerated dose) are measured up to 28 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06616155
Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of Michigan Rogel Cancer CenterInvestigator-initiated
~20 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionBone ScanComputed TomographyEnzalutamideRuxolitinib
At a glance
Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity (DLT)
Measured over Up to 28 days
+1 more outcome measured
Conditions
Where it's being run
3 sites across 2 statesMichigan2
Illinois1
Study leadership
- Zachery R Reichert · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 adenocarcinoma histology confirmation required
Ability to understand a written informed consent document, as determined by the study physician or designee
Surgical castration or continuous medical castration ≥ 8 weeks prior to screening; serum testosterone \< 50 ng/dL
Have progressed on prior abiraterone treatment by Prostate Cancer Working Group 3 prostate specific antigen (PSA) criteria
PSA must rise on two measurements at least 1 week apart in order to be eligible. Refer to PCWG3 for clarification.
Most Recent absolute PSA must be \> 2.0 ng/mL
Patient meets definition of poor responder to abiraterone by one of the following:
Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting (abiraterone started within 4 months of starting continuous androgen deprivation therapy \[ADT\]): \< 12 months duration on abiraterone
Abiraterone started in castration-resistant prostate cancer (CRPC) disease setting: \< 6 months duration on abiraterone due to progression or failure to achieve PSA50 response while on therapy
The patient's current or most recent treatment is ADT and abiraterone. Participants must sign consent within 30 days of discontinuing abiraterone or prior to stopping abiraterone
Patients must be willing to undergo metastatic tumor biopsy during screening. If no metastatic lesion is safely accessible to tumor biopsy, this requirement will not be required
50% of patients must have measurable disease by RECIST 1.1 criteria
Once 50% of total expected cohort has non-measurable disease, only patients with measurable disease by RECIST 1.1 criteria will be eligible. (Percentages with measurable disease are not relevant within dose escalation. Once dose expansion is started, those at expansion dose would be included in percentage evaluation.)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 (grade 2 ECOGs should be related to disease and thus potentially reversible)
A male participant must agree to use of contraception during the treatment period and for at least 90 days after the last dose of study drug. Female partners of male patients should also use contraception for 90 days after the last dose of study drug if they are of childbearing potential
Platelets ≥ 125,000/mm\^3 (obtained within 28 days prior to starting study therapy) (if creatinine clearance \[CrCl\] is between 30-59, the platelet entry criteria is \> 150,000/mm\^3)
Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained within 28 days prior to starting study therapy)
Hemoglobin ≥ 11 g/dL (obtained within 28 days prior to starting study therapy) No transfusions within 90 days prior to screening unless performed for acute bleeding
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (obtained within 28 days prior to starting study therapy) For patients with known liver metastasis: (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN
Bilirubin ≤ 1.5 the upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 x ULN. For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL (obtained within 28 days prior to starting study therapy)
Creatinine clearance (CrCl) ≥ 30 mL/min (obtained within 28 days prior to starting study therapy) For creatinine clearance estimation, the Cockcroft and Gault equation should be used
Exclusion
History of untreated (with radiotherapy and/or surgery) brain metastasis is not allowed (stable and treated metastases are allowed)
History of seizures or known hypersensitivity to enzalutamide, ruxolotinib or any of the excipients in the product
Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with the absorption of the study medications
Uncontrolled hypertension as indicated by systolic blood pressure (SBP) \> 170 mmHg or diastolic blood pressure (DBP) \> 105 mmHg on 2 consecutive measurements at screening visit unless known to have white coat hypertension syndrome
Have received chemotherapy in the metastatic castration-resistant setting (docetaxel within the hormone sensitive setting is allowed)
Failure to recover to grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study consent
Current active infection with any of the following: hepatitis B, hepatitis C, active tuberculosis, latent tuberculosis. Patients with well controlled HIV are eligible however all drug interactions with HIV drug and study therapies have to be reviewed
History of myocardial infarction, stroke, pulmonary embolism or deep vein thrombosis within 6 months of study enrollment
Study physician estimates life expectancy less than 6 months or patient is unable to swallow medications
Patients currently taking fluconazole
Currently receiving supplements containing androgens or medications known to be strong inhibitors of CYP2C8, strong inducers (except enzalutamide) or strong inhibitors of CYP3A4 and substrates of CYP3A4, CYP2C9 and CYP2C19 with a narrow therapeutic window. If substitution is possible, strong inducers, inhibitors and substrates must be discontinued at least 7 days or 5 half-lives (which ever longer) prior to the first administration of enzalutamide
Due to risk of tuberculosis (TB) reactivation, patients deemed at high risk by treating provider (e.g., close contact with someone with active TB, history of active/latent TB) should be excluded
Those with underlying hepatic disease with a CHILD-PUGH class A, B or C impairment are excluded
What this trial measures
- Dose-limiting toxicity (DLT)Up to 28 days
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.
- Maximum tolerated dose (MTD)Up to 28 days
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.