JPRN-UMIN000036395CompletedPhase 1
Phase I / IIa trial of R-OKY-034F for pancreatic cancer patients - Phase I / IIa trial of R-OKY-034F for pancreatic cancer patients
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Osaka University Hospital
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 80years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
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
Investigators
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