Phase I / IIa trial of R-OKY-034F for pancreatic cancer patients

JRCT ID: jRCT2051190003

Registered date:03/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 01/03/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Under hospitalization, R-OKY-034F once a day for 28 days orally

Outcome(s)

Primary Outcome

safety
1) Determination of dose-limiting toxicity (DLT) of R-OKY-034F
Determination of the maximum dose (MTD) of 2) R-OKY-034F

Effectiveness
1) Calculation of response rate and disease control rate for each dose when R-OKY-034F is administered

Secondary Outcome

safety
1) Adverse events and frequency of each dose when R-OKY-034F is administered

Effectiveness
1) Calculation of stable period
2) Calculation of survival time
3) The concentration of R-OKY-034F in blood and urinary metabolites are measured over time and analyzed according to descriptive statistics

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: 79age
• Gender: Both

Include 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

Exclude 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 (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

Related Information

• Primary Sponsor: Takehara Tetsuo
• Source(s) of Monetary Support: J-pharma Co., Ltd.,Japan Agency for Medical Research and Development