A Phase I Trial of MEK Inhibitor MEK 162 Combined Sequentially With Gemcitabine-Oxaliplatin (GEMOX) in Patients With Advanced Biliary Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Total incidence of grade 3 and 4 adverse events
研究概览
简要总结
This is a phase I study (an early study to check the safety of a new drug or drug combination) to find the safest and most tolerated dose of the combination of oxaliplatin with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers and cancers associated with the bile ducts leading from the gallbladder and to and from the liver) that is not curable by surgery and/or has spread beyond the biliary tree (place where cancer started). Everyone will receive the same standard doses of oxaliplatin and gemcitabine but may receive different doses of MEK 162.
MEK 162 is a new drug which plays an important role in the regulation of cell growth and has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. This type of drug has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary 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
- •Histopathological or cytological diagnosis of non-resectable, recurrent or metastatic biliary tract (intra- or extra-hepatic) or gallbladder carcinoma.
- •Have measurable disease.
- •Not received prior systemic therapy for advanced biliary cancer.
- •Age 18 years of age or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or
- •Estimated life expectancy is greater than 3 months.
- •Have adequate hematological function.
- •Have adequate cardiac function.
- •All radiology studies performed within 4 weeks prior to the start of therapy.
- •No evidence of active uncontrolled infection.
- •Ability to understand and willing to sign a written informed consent document.
- •Ongoing prior toxicities related to previous treatments received to grade 1 or less at time of registration.
- •Able to take oral medications.
排除标准
- •Progressing within 6 months of receiving adjuvant treatment for biliary tract cancer.
- •Not have received prior chemotherapy for non-resectable or metastatic disease or MEK inhibitor.
- •Histopathological or cytological diagnosis of ampullary carcinoma.
- •Incomplete recovery from previous surgery.
- •Undergoing current treatment with curative intent.
- •History of prior malignancy that could interfere with the response evaluation.
- •Any evidence of severe or uncontrolled systemic diseases or laboratory findings that may affect participation in the trial.
- •Any psychiatric or other disorder likely to impact on informed consent.
- •Pregnant or nursing (lactating) women.
- •Agree to use highly effective methods of contraception throughout the study and for 6 months after study drug discontinuation.
- •Significant cardiac disease.
- •History of retinal degenerative disease.
- •History of Gilbert's syndrome.
- •Known positive serology for HIV, active hepatitis B, and/or active hepatitis C infection.
- •Neuromuscular disorders that are associated with elevated creatine kinase.
- •Planning on embarking on a new strenuous exercise regimen after first dose of study treatment.
- •Impairment of gastrointestinal function or gastrointestinal disease.
- •Any other condition that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures.
研究组 & 干预措施
MEK 162, gemcitabine, and oxaliplatin
MEK 162 (30 mg or 45 mg by mouth), twice a day, every day. Gemcitabine (1000 mg/m2 by vein), followed by oxaliplatin (85 mg/m2 by vein) every 2 weeks.
干预措施: MEK 162 (Drug)
MEK 162, gemcitabine, and oxaliplatin
MEK 162 (30 mg or 45 mg by mouth), twice a day, every day. Gemcitabine (1000 mg/m2 by vein), followed by oxaliplatin (85 mg/m2 by vein) every 2 weeks.
干预措施: Gemcitabine (Drug)
MEK 162, gemcitabine, and oxaliplatin
MEK 162 (30 mg or 45 mg by mouth), twice a day, every day. Gemcitabine (1000 mg/m2 by vein), followed by oxaliplatin (85 mg/m2 by vein) every 2 weeks.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Total incidence of grade 3 and 4 adverse events
时间窗: 2 years
Total rate of grade 3 and 4 adverse events
时间窗: 2 years
Maximum dose level at which 0/3 patients or 1/6 patients experience dose-limiting toxicity
时间窗: 2 years
次要结局
- Number of patients with objective response rate(2 years)