Pancreatic cancer
Conditions
Interventions
R-OKY-034F once a day for 28 days orally 1, 2.5, 5, 10, 15 mg/kg Post-observation period: 14 days
Sponsors
Osaka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 3) Age 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
Exclusion criteria
Exclusion criteria: 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 3) Other * Women and men who can not agree to the practice of highly effective contraception * Patients who the investigator or subinvestigator judged as inappropriate for trial entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <safety> 1) Determination of dose-limiting toxicity (DLT) of R-OKY-034F 2)Determination of the maximum dose (MTD) of R-OKY-034F <Effectiveness> 1) Calculation of response rate and disease control rate for each dose when R-OKY-034F is administered | — |
Countries
Japan
Contacts
Public ContactHideaki Harada
Osaka University Department of Medical Innovation
Outcome results
None listed