A Phase III Study of Capecitabine with Ruxolitinib or Placebo to Treat Advanced Pancreatic Cancer

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 2 Study)

Purpose

In this study, researchers are assessing the effectiveness of giving the anticancer drug capecitabine with ruxolitinib or a placebo in patients with metastatic pancreatic cancer that has continued to grow despite initial therapy. Ruxolitinib works by interfering with inflammation and metabolism in cancer cells. It is approved for treating a blood disease called myelofibrosis, but its use in pancreatic cancer is considered investigational.

Capecitabine is commonly used to treat advanced cancers of the pancreas, breast, and colon, although its use in pancreatic cancer is also considered investigational. Patients in this study will be randomly assigned to receive either capecitabine combined with ruxolitinib, or capecitabine combined with a placebo (inactive drug). All of the medications used in this study are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic pancreatic cancer that has continued to grow despite no more than one prior regimen of therapy for advanced cancer.
  • At least 2 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eileen O’Reilly at 646-888-4182.

Protocol

14-190

Phase

III

Investigator

Co-Investigators