JPRN-jRCT2051190003已完成1 期
Phase I / IIa, single-institution, open-label study to explore the safety and efficacy of R-OKY-034F in patients with refractory / intolerable and surgically unresectable pancreatic cancer with standard chemotherapy
Takehara Tetsuo0 个研究点目标入组 30 人开始时间: 2019年4月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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 至 79age（—）
- 性别
- All
入选标准
- •1) Disease
- •Patients who have been diagnosed with pancreatic ductal cancer pathologically or histologically
- •2) Clinical stage of disease
- •Image diagnosis by contrast-enhanced CT or contrast-enhanced MRI within 14 days prior to registration, Diagnoses of Pancreatic cancer medical care guidelines 2016 edition: How is the resectability of pancreatic cancer determined? Patient
- •Patients who are refractory or intolerant of both gemcitabine-based standard chemotherapy and 5-FU-based standard chemotherapy and have no other standard chemotherapy available
- •Patients aged 20 and over and under 80 at the time of enrollment
- •4) PS: Performance status
- •Patients with PS 0 to 2
- •5) Evaluation possibility of lesion
- •Patients with one or more measurable lesions defined by RECIST criteria
- •6) Consent
- •Patients who have obtained informed consent from patients themselves regarding clinical trial participation
- •7) prognosis
- •Patients with a prognosis of more than 2 months
排除标准
- •1) Duplicate cancer
- •Patients with active double cancer.
- •However, we do not exclude duplicate cancers that do not affect safety and efficacy assessment.
- •2) Items related to complications
- •-Patients with unstable angina (angina pectoris onset or attack worsening within 3 weeks before enrollment), or patients with a history of myocardial infarction within 6 months
- •- Patients with QtcE prolongation of 450 ms or more
- •- Patients with interstitial lung disease or patients with previous history
- •-Patients with high degree of disability due to respiratory disease (interstitial lung disease, radiation lung injury etc.) (grade 3 or higher on the modified MRC scale)
- •- Patients with high physical activity restriction due to heart failure (NYHA class III or higher)
- •- Patients with intestinal paralysis, intestinal obstruction or severe diarrhea
- •- Patients who have the following abnormal values for kidney function, liver function and bone marrow function at screening test
- •-Moderate or higher renal dysfunction with GFR estimate less than 45 ml / min / 1.73 m2
- •-Moderate or more liver dysfunction, with either AST or ALT> 100 IU / L
- •-Leukocytes: less than 3,000 / microL
- •-Neutrophils: less than 1,500 /microL
- •-Platelet: less than 75,000 / microL
- •-Hemoglobin: less than 8.0 g / dL
- •-Total bilirubin: 2.5 mg / dL or more
- •- Patients weighing less than 40 kg
- •- Pregnant women
- •- Breastfeeding women
- •(It is not this limitation if it is possible to refrain from breastfeeding for 14 days after the final oral administration from the study drug oral administration start date)
- •- Patients who are complicated by psychosis or psychiatric symptoms and judged as difficult to participate in clinical trials
- •- Women and men who can not agree to the practice of highly effective contraception (intrauterine contraceptive devices (IUD, IUS), use of condoms with a spermicide-containing jelly, combined use of condoms and pessaries, etc.) under the guidance of a doctor Between the date of consent acquisition and the last 14 days after oral administration)
- •- Patients who the investigator or subinvestigator judged as inappropriate for trial entry
研究者
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