A Multicenter Phase I/II Study of Cabozantinib Alone or in Combination with Panitumumab in Patients with MET-amplified metastatic colorectal cancer

ational Cancer Center Hospital East0 个研究点目标入组 54 人开始时间: 2019年3月22日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 54

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

入排标准

年龄范围: >= 20age old 至 ot applicable（—）
性别: All

入选标准

•1. Informed consent for participation in the study is obtained at the discretion of the patient.
•2. RAS and BRAF V600E gene wild types as determined by tumor tissue assay
•3. Phase 1 part only: RAS and BRAF V600E gene wild types as determined by liquid biopsy assay in cases of prior treatment with anti-EGFR antibody
•4. Phase 2 part only: Patients with MET amplification as determined by liquid biopsy analysis
•5. Phase 1 part only: Patients not responding to, or not tolerating, at least one regimen of chemotherapy containing fluoropyrimidine drugs, oxaliplatin, and irinotecan in treatment for mCRC (irrespective of whether an anti-EGFR antibody was administered, and irrespective of whether an anti-VEGF antibody was administered).
•6. Phase 2 part only: Patients not responding to, or not tolerating, at least one chemotherapy regimen (including irinotecan or oxaliplatin) containing fluoropyrimidine drugs in treatment for mCRC (irrespective of whether an anti-VEGF antibody was administered).
•7. Phase 2 part only: Patients who did not respond to anti-EGFR antibody drug (either panitumumab or cetuximab)

排除标准

•1. History of prior monoclonal antibody, chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or not recovered (i.e., not greater than Grade 1 or at baseline) from adverse events due to a previously administered agent
•2. History of surgical treatment and radiotherapy within 2 weeks before enrollment
•3. Symptomatic brain metastases or meningeal dissemination
•4. Inadequately controlled hypertension
•5. Known acute or chronic pancreatitis
•6. Medical history of clinically significant cardiac diseases
•7. Gastrointestinal function or gastrointestinal diseases that significantly interfere with absorption, distribution, metabolism, and excretion of the study drugs
•8. History of other malignant tumors within 3 years before enrollment in the study
•9. Medical history of thromboembolism within 6 months
•10. Concomitant anticoagulation, with oral anticoagulants or platelet inhibitors
•11. Interstitial lung disease with symptoms or signs of activity
•12. Known allergy or hypersensitivity to any of the components of cabozantinib tablets
•13. History of abdominal fistula and/or gastrointestinal perforation within 6 months before enrollment.
•14. Non-healing wound, non-healing ulcer, or non-healing bone fracture
•15. Any hemorrhage or bleeding event, greater than or equal to CTCAE Grade 3, within 4 weeks before enrollment
•16. Cavitating pulmonary lesions or known endobronchial disease manifestation
•17. Lesions invading major pulmonary blood vessels

研究者

发起方

ational Cancer Center Hospital East

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