Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Percentage of patients who experience complete response, partial response, or stable disease
研究概览
简要总结
This is a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful the combination of two drugs, panitumumab and trametinib, are in patients with advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).
Panitumumab is a drug that is approved by Health Canada for the treatment of advanced colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the protein, epidermal growth factor receptor (EGFR) from working.
Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working.
Previous studies have shown that the combination of panitumumab and trametinib may be more useful in KRAS, NRAS, or BRAF wild type colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •KRAS/NRAS/BRAF wild type colorectal cancer, not responsive to standard therapies, no approved or curative therapy, refuse standard therapy
- •Prior 5-FU, oxaliplatin and irinotecan
- •ECOG Performance Status of 0 or 1
- •Able to swallow/retain oral drugs
- •Able and agree to have provide tumor tissue/have biopsies
- •Agree to use contraception
- •Not pregnant
- •Adequate organ system function
排除标准
- •Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapies <28 days or 5 half lives
- •Prior EGFR, MEK, or RAF inhibitor or regorafenib
- •Current use of prohibited medications
- •Unresolved side effects
- •GI disease or other condition affecting GI absorption
- •Mucosal or internal bleeding
- •Any major surgery <four weeks
- •HIV, HBV, or HCV positive
- •Active infection
- •Leptomeningeal disease
- •Brain metastases
- •Unacceptable QTcF interval
- •Significant uncontrolled arrhythmias
- •Acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting < 6 mos.
- •Class II, III, or IV heart failure
- •Other clinically significant ECGs
- •Intra - cardiac defibrillators
- •Cardiac metastases
- •Condition that may interfere with patient safety
- •Hypersensitivity to study drugs
- •Severe or uncontrolled systemic diseases
- •Pregnant or lactating
- •Retinal vein occlusion
- •Interstitial lung disease or pneumonitis
- •Active liver or biliary disease
研究组 & 干预措施
Trametinib and Panitumumab
Trametinib: 2 mg QD, orally, continuously.
Panitumumab: 6 mg/kg, intravenously, Q2W
干预措施: Trametinib (Drug)
Trametinib and Panitumumab
Trametinib: 2 mg QD, orally, continuously.
Panitumumab: 6 mg/kg, intravenously, Q2W
干预措施: Panitumumab (Drug)
结局指标
主要结局
Percentage of patients who experience complete response, partial response, or stable disease
时间窗: 24 weeks
by RECIST 1.1 criteria
次要结局
- Frequency and proportion of patients who experience side effects.(3 years)
- Time period from the first dose of Trametinib and Panitumumab to the first date in which progression or death is observed(3 years)
- Date of first confirmed response to the first date in which progression is observed(3 years)
- Proportion of subjects achieving either a complete or partial tumor response(3 years)