A Study of Ruxolitinib in Pancreatic Cancer Patients

NCT02119663 ↗

Phase 3 Terminated 86 enrolled Incyte Corporation

RandomizedParallel-groupDouble-blindTreatment

Summary

This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.

Timeline

Start: 2014-06
Primary completion: 2016-02
Completion: 2016-10

Outcome

Missed primary endpoint

Stopped: “The safety committee found no safety issues but recommended halting the study based on a lack of efficacy in a similar trial. The sponsor terminated the trial.”

paper Ruxolitinib plus capecitabine was well tolerated in refractory pancreatic cancer patients; this combination did not improve survival. PMID 29508247 ↗

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