EUCTR2013-004714-18-ES进行中（未招募）1 期
A Randomized, Double-Blind Study of Ruxolitinib or Placebo inCombination With Regorafenib in Subjects With Relapsed orRefractory Metastatic Colorectal Cancer - Ruxolitinib in Combination With Regorafenib in Metastatic Colorectal Cancer
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
- 420
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 colon or rectum that is metastatic.
- •- Previous treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF therapy (if no contraindication); and if KRAS wild type and no contraindication, an anti-EGFR therapy; and progressed following the last administration of approved therapy.
- •- Radiographically measurable or evaluable disease (per RECIST 1.1).
- •- Eastern Cooperative Oncology Group performance status of 0 to 2.
- •- Three or more weeks have elapsed from the completion of previous treatment regimen and subjects must have recovered or be at a new stable baseline from any related toxicities.
- •- Radiotherapy to disease sites is allowed provided:
- •- Four or more weeks have elapsed since the completion of radiation therapy.
- •- Subjects who received palliative radiation treatment to a limited field or on an accelerated schedule within the last 7 days are eligible
- •- Disease sites within the field of prior irradiation have subsequently progressed or there are other metastatic disease sites outside the field of prior irradiation.
- •- All treatment related toxicities have resolved or are at a new stable baseline.
- •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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 210
排除标准
- •Subjects who meet any of the following will not be included in the study:
- •- Received prior treatment with regorafenib.
- •- Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
- •- History of abdominal fistula or gastrointestinal perforation at any point within 6 months prior to day 1 of study drug administration, unless surgically repaired.
- •Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), diverticulitis, or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding.
- •- Recent history (?4 weeks of Day 1 of study drug administration) of a major surgery or significant traumatic injury.
- •- Recent history (? 3 months) or ongoing partial or complete bowel obstruction unless corrected with surgery.
- •- Blood pressure ? 140/90 mmHg
- •- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
- •- Known 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 II, III, or IV congestive heart failure, and arrhythmia requiring therapy.
- •- Creatinine clearance < 50 mL/min measured or calculated by Cockroft-Gault equation
- •- Inadequate hepatic, and bone marrow function as evidenced by:
- •- Absolute neutrophil count < 1.5 × 109/L.
- •- Platelets < 100 × 109/L.
- •- Hemoglobin < 9 g/dL (transfusions are permitted to achieve baseline hemoglobin level).
- •- ALT/AST > 2.5 × the 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 the subject may participate if the direct bilirubin is ? 1.5 × ULN).
- •- Concurrent anticancer therapy
- •- Subjects who participated in any other study in which an investigational study drug was received within 28 days prior to first dose.
- •- Current or previous other malignancy within 5 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 malignancy.
- •- Known HIV infection.
- •- HBV or HCV viremia or at risk for HBV or HCV reactivation.
研究者
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