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New treatment option for Castration-Resistant Prostate Carcinoma
Official title Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT06616155
What this study is testing
What is Enzalutamide?
Enzalutamide is an investigational medicine, being studied as a potential treatment for castration-resistant prostate carcinoma.
Also referred to as ASP9785, MDV 3100.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I/II tests the safety, side effects and best dose of ruxolitinib in combination with enzalutamide and how well it works in treating patients with prostate cancer that remains despite blocking hormone production (castration-resistant) and that has spread from where it first started to other places in the body (metastatic). Ruxolitinib, a kinase inhibitor, slows down the growth of the tumor by blocking the proteins, JAK1 and JAK2, tumors use to grow.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information...
- 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
You likely can't join if
- 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...
- Uncontrolled hypertension as indicated by systolic blood pressure (SBP) \> 170 mmHg or diastolic blood pressure (DBP) \> 105 mmHg on 2 consecutive...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- Bilirubin ≤ 1.5 the upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 x ULN. For people with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL (obtained within 28...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Ann Arbor, Michigan, United States; Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.