None listed
Conditions
Interventions
Subjects will be randomized (1:1) to one of the following treatment groups:
• Treatment A: Capecitabine (2.000 mg/m2 on approximately equal doses twice a day) given in combination with ruxolitinib
Sponsors
INCYTE CORPORATION,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: • Male or female, 18 years or older. • Histologically or cytologically confirmed adenocarcinoma of the pancreas. • Advanced adenocarcinoma of the pancreas that is inoperable or metastatic. • mGPS of 1 or 2 as defined below: − mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ≥ 35 g/L − mGPS of 2: CRP > 10 mg/L and albumin 1.5 × ULN then direct bilirubin must be ≤ 1.5 × ULN (use of biliary stent to achieve bilirubin levels is permitted). − Alkaline phosphatase 16 kg/m2. − Absence of significant concurrent, uncontrolled medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease. − Able to swallow and retain oral medication. • ≥ 2 weeks elapsed from the completion of previous treatment regimen and subjects must have recovered or be at a new stable baseline from any related toxicities. • Radiographically measurable or evaluable disease (based on local evaluation), per RECIST (v1.1).
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: • Received more than 1 prior regimen (eg, chemotherapy, biologic, targeted, immune, investigational therapies alone or in combination) for advanced or metastatic disease. • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment. • Known brain or central nervous system metastases or history of uncontrolled seizures. • Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy. • Ongoing radiation therapy or 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). • Subjects who participated in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to the first dose. • Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval. • Recent (≤ 3 months) history or ongoing partial or complete bowel obstruction, unless surgically corrected. • Prior severe reaction to fluoropyrimidines, known DPD deficiency, or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients. • Known history of human immunodeficiency virus infection. • Active hepatitis B or C infection that requires treatment. • Unwilling to be transfused with blood components. • Prior treatment with a JAK inhibitor for any indication.
Countries
Argentina, Austria, Brazil, Chile, Colombia, Denmark, France, Ireland, Israel, Mexico, Netherlands, Portugal, Sweden, United States
Contacts
Public ContactJose Eduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed