Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

Phase 3 Terminated 321 enrolled Incyte Corporation

RandomizedParallel-groupDouble-blindTreatment

Summary

Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

Timeline

Start: 2014-03
Primary completion: 2016-02
Completion: 2016-12

Outcome

Missed primary endpoint

Stopped: “The study was terminated early based on the results of the planned interim analysis.”

paper There was no significant difference in OS or progression-free survival (PFS) between treatments in JANUS 1 PMID 29508247 ↗

release “JANUS 1 demonstrated that ruxolitinib plus capecitabine did not show a sufficient level of efficacy to warrant continuation.” incyte.com ↗

Publications

Hurwitz H, Van Cutsem E, Bendell J, Hidalgo M, Li CP, Salvo MG, Macarulla T, Sahai V, Sama A, Greeno E, Yu KH, Verslype C, Dawkins F, Walker C, Clark J, O'Reilly EM. Ruxolitinib + capecitabine in advanced/metastatic pancreatic cancer after disease progression/intolerance to first-line therapy: JANUS 1 and 2 randomized phase III studies. Invest New Drugs. 2018 Aug;36(4):683-695. doi: 10.1007/s10637-018-0580-2. Epub 2018 Mar 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ruxolitinib	Small molecule	15 mg	Oral
Background	Capecitabine	Small molecule	2000 mg/m2	Oral