A Study of Ruxolitinib in Pancreatic Cancer Patients

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pancreatic Cancer

In brief

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

Key facts

Study ID

NCT02119663

Run by

Incyte Corporation

People needed

86

Starts

2014-06-01

Expected to finish

2016-10-01

Last updated by the study team

2018-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the pancreas.
• Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
• ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
• Radiographically measurable or evaluable disease
• An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
• Criteria:
• mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ≥ 35 g/L
• mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L

You may not qualify if…

• Received more than 1 prior regimen for advanced or metastatic disease.
• Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment
• Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
• Current or previous other malignancy within 2 years of study entry without sponsor approval
• Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), ruxolitinib, or any of their excipients.
• Prior treatment with a JAK inhibitor for any indication.

Where it is running

• Study site — Fayetteville, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — La Jolla, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Fort Myers, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Athens, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Thomasville, Georgia, United States
• Study site — Harvey, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Kansas City, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Farmington Hills, Michigan, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Lansing, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Saint Louis Park, Minnesota, United States
• Study site — Bolivar, Missouri, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.