A Phase 1b/2, Open-label, Multicenter Study of Novel Oncology Therapies in Combination with Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1) - COLUMBIA-1

AstraZeneca AB0 个研究点目标入组 114 人开始时间: 2019年8月9日最近更新: 2019年12月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AstraZeneca AB
入组人数: 114

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
•Age = 18 years at the time of screening.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Patients must have histologic documentation of advanced or metastatic colorectal cancer and:
•- A documented mutation test during screening and confirmed tumor locations from disease assessment for enrollment.
•- Patients must NOT have defective DNA mismatch repair (microsatellite instability) as documented by testing.
•- Patients must not have received any prior systemic therapy for recurrent/metastatic disease (prior adjuvant chemotherapy or radio-chemotherapy is acceptable so long as progression was not within 6 months of completing the adjuvant regimen).
•Patients must have at least one lesion that is measurable by RECIST v1.1 (Eisenhauer et al, 2009).
•Patients must have adequate organ function.
•Patients with medical conditions requiring systemic anticoagulation (eg, atrial fibrillation) are eligible provided that both of the following criteria are met:
•- The patient has an in-range international normalized ratio (INR) on a stable dose of oral anticoagulant or be on a stable dose of low molecular weight heparin.
•- The patient has no active bleeding or pathological condition that carries a high risk of bleeding.
•Body weight > 35 kg.
•Adequate method of contraception per protocol.
•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 53
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 53

排除标准

•History of allogeneic organ transplantation.
•Active or prior documented autoimmune disorders within the past 5 years
•History of venous thrombosis within the past 3 months
•Cardiovascular criteria:
•- Presence of acute coronary syndrome including myocardial infarction or unstable angina pectoris, other arterial thrombotic event including cerebrovascular accident or transient ischemic attack or stroke within the past 6 months.
•- New York Heart Association (NYHA) class II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or uncontrolled hypertension.
•- History of hypertensive crisis/hypertensive encephalopathy within the past 6 months
•Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) = 470 ms
•No significant history of bleeding events or gastrointestinal perforation
•Uncontrolled intercurrent illness
•History of another primary malignancy except for:
•- Malignancy treated with curative intent and with no known active disease = 5 years of low potential risk for recurrence.
•- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
•- Adequately treated carcinoma in situ without evidence of disease.
•History of active primary immunodeficiency
•Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
•Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
•Any unresolved toxicity NCI CTCAE Grade > 1 from previous anticancer therapy.
•History of leptomeningeal disease or cord compression.
•Untreated central nervous system (CNS) metastases
•Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
•Known dihydropyrimidine dehydrogenase (DPD) deficiency.
•Prior immunotherapy or anti-angiogenics.
•Receipt of live attenuated vaccine within the past 30 days.
•Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days.
•Current or prior use of immunosuppressive medication within the past 14 days, with exceptions per protocol.

研究者

发起方

AstraZeneca AB

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