Male or female, 18 years or older with histologically or cytologically confirmed adenocarcinoma of the pancreas that is inoperable or metastatic. MedDRA version: 17.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 100000004864 MedDRA version: 17.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Jakafi
Product Name: ruxolitinib
Product Code: INCB018424
Pharmaceutical Form: Tablet
INN or Proposed INN: ruxolitinib
CAS Number: 941678-49-5
Current Sponsor code: INCB018424
Other descri
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 >10 mg/L and albumin = 35 g/L -mGPS of 2: C-Reactive protein >10 mg/L and albumin 1.5 × ULN then direct bilirubin must be = 1.5 × ULN. -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). -Measurable lesions may be in the field of prior radiation; however, there must be at least a 4-week period between the last radiation treatment and demonstration of interval progression of the lesion compared with the baseline scan documenting disease status for the lesion to be considered measurable. •Females are either postmenopausal for at least 1 year with documented follicle-stimulating hormone (FSH) > 30 IU/L, are surgically sterile for at least 3 months, or must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through follow-up if of childbearing potential. (Note: Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subjects and their understanding confirmed). For all females, the pregnancy test result must be negative at screening
Exclusion criteria
Exclusion criteria: • Received more than 1 prior chemotherapy regimen 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 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, radiation therapy administered within 30 days of enrollment, or prior history of radiation therapy to = 25% of the bone marrow •Subjects who received palliative radiation treatment to a limited field or on an accelerated schedule within the last 30 days are eligible for enrollment, provided at least 7 days have elapsed from completion of radiation therapy prior to the first dose and all treatment related toxicities have resolved or are at a new stable baseline. •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 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 due to the disease understudy and surgically corrected. •Prior severe reaction to fluoropyrimidines, known DPD deficiency, or other known sensitivity to 5-FU. •Known history of human immunodeficiency virus (HIV) infection. •Active hepatitis B or C infection that requires treatment. •Unwilling to be transfused with blood components. •Pregnant or breastfeeding women. •Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations. •Any condition in the judgment of the investigator that would jeopardize the safety of the subject or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare the OS of subjects with advanced or metastatic adenocarcinoma of the pancreas when treated with ruxolitinib in combination with capecitabine versus capecitabine alone.;Primary end point(s): Overall survival as determined from the date of randomization until death due to any cause.;Secondary Objective: To evaluate and compare the efficacy of the 2 treatment groups with respect to PFS. To evaluate and compare the efficacy of the 2 treatment groups with respect to overall tumor response and duration of response. To evaluate and compare the safety and tolerability of ruxolitinib in combination with capecitabine versus capecitabine alone. ;Timepoint(s) of evaluation of this end point: This study is event-driven and will complete when 262 deaths (combined across the 2 treatment groups) occur in the study, presuming that the study will not have been stopped earlier for futility, efficacy, or safety considerations. In this study, approximately 310 subjects will be randomized 1:1 between ruxolitinib and placebo over an approximate 18-month period. Assuming uniform accrual over the 18-month period, exponential survival on both placebo (median OS of 2 months) and ruxolitinib (median OS of 3 months), the targeted number of deaths is expected 2 months after the last subject starts treatment in the randomized portion of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression-free survival defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause, if sooner. Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment. Safety and tolerability of the treatment regimens through assessment of AEs and changes in safety assessments including laboratory parameters. ;Timepoint(s) of evaluation of this end point: This study is event-driven and will complete when 262 deaths (combined across the 2 treatment groups) occur in the study, presuming that the study will not have been stopped earlier for futility, efficacy, or safety considerations. In this study, approximately 310 subjects will be randomized 1:1 between ruxolitinib and placebo over an approximate 18-month period. Assuming uniform accrual over the 18-month period, exponential survival on both placebo (median OS of 2 months) and ruxolitinib (median OS of 3 months), the targeted number of deaths is expected 2 months after the last subject starts treatment in the randomized portion of the study. | — |
Countries
Australia, Belgium, Canada, European Union, Italy, Korea, Republic of, New Zealand, Spain, Taiwan, Thailand, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
Incyte Corporation
Outcome results
None listed