Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• 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

• Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

1. mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L

2. mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L

Exclusion Criteria:

• 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).

• Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.

• Prior treatment with a JAK inhibitor for any indication.