jRCT2080224606已完成2 期
A Multicenter Phase I/II Study of Cabozantinib Alone or in Combination with Panitumumab in Patients with MET-amplified metastatic colorectal cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- An open-label, single arm phase I study and an open-label, randomized controlled multicenter phase II study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Informed consent for participation in the study is obtained at the discretion of the patient.
- •RAS and BRAF V600E gene wild types as determined by tumor tissue assay
- •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
- •Phase 2 part only: Patients with MET amplification as determined by liquid biopsy analysis
- •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).
- •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).
- •Phase 2 part only: Patients who did not respond to anti-EGFR antibody drug (either panitumumab or cetuximab)
排除标准
- •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
- •History of surgical treatment and radiotherapy within 2 weeks before enrollment
- •Symptomatic brain metastases or meningeal dissemination
- •Inadequately controlled hypertension
- •Known acute or chronic pancreatitis
- •Medical history of clinically significant cardiac diseases
- •Gastrointestinal function or gastrointestinal diseases that significantly interfere with absorption, distribution, metabolism, and excretion of the study drugs
- •History of other malignant tumors within 3 years before enrollment in the study
- •Medical history of thromboembolism within 6 months
- •Concomitant anticoagulation, with oral anticoagulants or platelet inhibitors
- •Interstitial lung disease with symptoms or signs of activity
- •Known allergy or hypersensitivity to any of the components of cabozantinib tablets
- •History of abdominal fistula and/or gastrointestinal perforation within 6 months before enrollment.
- •Non-healing wound, non-healing ulcer, or non-healing bone fracture
- •Any hemorrhage or bleeding event, greater than or equal to CTCAE Grade 3, within 4 weeks before enrollment
- •Cavitating pulmonary lesions or known endobronchial disease manifestation
- •Lesions invading major pulmonary blood vessels
研究者
研究点 (1)
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