EUCTR2014-000294-39-FR进行中（未招募）1 期
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 2 Study) - The JANUS 2 Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 < 35 g/L
- •Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
- •Use of a fluoropyrimidine-containing regimen (eg, FOLFIRNOX, FOLFOX, CapeOx, etc) in the first-line setting is permitted provided the subject discontinued treatment for reasons other than disease progression and the subject received = 2 cycles of therapy. Subjects who received single-agent capecitabine as first-line therapy are not eligible.
- •Able to tolerate and benefit from therapy as evidenced by:
- •Absolute neutrophil count = 1.5 × 109/L with white blood cell count < 20 × 109/L.
- •Platelets = 75 × 109/L.
- •Hemoglobin = 9 g/dL (transfusions are permitted to achieve baseline hemoglobin level).
- •Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) = 2.5 × upper limit of normal (ULN); or = 5 × ULN in the presence of liver metastases.
- •Total bilirubin = 1.5 × ULN; if total bilirubin is > 1.5 × ULN then direct bilirubin must be = 1.5 × ULN (use of biliary stent to achieve bilirubin levels is permitted).
- •Alkaline phosphatase < 3 × ULN.
- •Lactate dehydrogenase (LDH) < 3 × ULN in the absence of hemolysis.
- •Creatinine clearance = 50 mL/min measured or calculated by Cockroft-Gault equation or the estimated glomerular filtration rate (GFR) = 50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula.
- •ECOG performance status 0 to 2.
- •Body mass index (BMI) > 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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •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 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 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 sensitivity to fluorouracil (5-FU).
- •Known history of human immunodeficiency virus infection.
- •Active hepatitis B or C infection that requires treatment.
- •Unwilling to be transfused with blood components.
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