Trial Details

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)

NCT02117479

TERMINATED

DESCRIPTION

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

CONDITIONS

ELIGIBILITY 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.