The JANUS 1 Study Incyte INCB 18424-362
Research type
Research Study
Full title
A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor, Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 1 study)
IRAS ID
156913
Contact name
John Bridgewater
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2014-000293-20
Research summary
Ruxolitinib (Jakafi®) is approved for disorder of bone marrow (myelofibrosis) and is currently in development for the treatment of solid tumours. Ruxolitinib strongly reduces the activitiy of the JAK proteins TKs (an enzyme (protein) involved in cell signalling in body). By reducing the TKs, It is believed that Ruxolitinib will reduce the symptoms of pancreatic cancer as well as show how severe certain pancreas is damaged by tumour.
The mortality (death) rate from pancreatic cancer is high. Most die from the disease because it commonly presents in an advanced state. Chemotherapy (special treatment for cancer patients) is the initial therapy for patients with advanced disease, however, there is currently no approved standard of care for patients with pancreatic cancer who have progressive disease (PD) despite first-line therapy. Guidelines encourage the participation of patients with recurrent or hard-to-treat advanced pancreatic cancer and satisfactory performance status in clinical studies.
This study is primarily designed to see whether Overall Survival of subjects with pancreatic cancer can be improved when treated with Ruxolitinib in combination with Capecitabine versus Capecitabine alone. Therefore half of patients will take Capecitabine 2000 mg/m2 daily (1000 mg/m2 twice daily) and Ruxolitinib 15 mg BID, whereas another half will take Capecitabine 2000 mg/m2 daily (1000 mg/m2 BID) and placebo (administered twice daily). Total 310 subjects with advanced or metastatic cancer of the pancreas who have failed, or were intolerant to first-line chemotherapy will be randomised (1:1) to one of the treatment groups. Treatment for all subjects will continue as long as the subjects can cope with the treatment, and the subject does not meet the discontinuation criteria. Subjects who discontinue study treatment (study drug and Capecitabine) will continue to be followed for subsequent anticancer treatments and survival at least every 6 weeks.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1014
Date of REC Opinion
11 Jul 2014
REC opinion
Further Information Favourable Opinion