Study of Ruxolitinib in Pancreatic Cancer Patients

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• 18 years of age or older

• Diagnosis of metastatic pancreatic cancer; subjects must have had measurable, or evaluable disease that was histologically confirmed

• Karnofsky performance status of ≥ 60

• Subjects must have failed 1st-line gemcitabine treatment for metastatic pancreatic cancer:

o An alternate chemotherapeutic agent was an acceptable substitute as 1st-line therapy in the event that the subject was intolerant to or ineligible to receive gemcitabine

• ≥ 2 weeks elapsed from the completion of previous chemotherapy, and subjects must have recovered or been at new stable baseline from any related toxicities

Exclusion Criteria:

• More than 1 prior chemotherapy regimen (not including adjuvant therapy) for metastatic disease

• Evidence of central nervous system (CNS) metastases (unless stable for > 3 months) or history of uncontrolled seizures

• Ongoing radiation therapy or prior radiation therapy administered as a second-line treatment

• Other active malignancy except basal or squamous carcinoma of the skin

• Inability to swallow food or any condition of the upper GI tract that precluded administration of oral medications

• Inadequate renal, hepatic and bone marrow function demonstrated by clinical observations and/or laboratory assessments