Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b/2a Multicenter Study of Ruxolitinib and Enzalutamide in Castration Resistant Prostate Cancer
Sponsor: University of Michigan Rogel Cancer Center + Incyte Corporation
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Dose-limiting toxicity (DLT)
Time frame: Up to 28 days
Maximum tolerated dose (MTD)
Time frame: Up to 28 days
Secondary Endpoints
Rate of response
Eligibility Criteria
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 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 ca…
Read full criteria on CT.gov →✦ Analyst Commentary
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