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

JRCT ID: jRCT2051200105

Registered date:24/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 17/09/2019
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Once a day for orally
1mg/kg, 2.5mg/kg, 5mg/kg, 10mg/kg, 15 mg/kg

Outcome(s)

• Primary Outcome: Adverse Event and Side Effect

Secondary Outcome

1. Progression-free survival (PFS)
2. PFS at 3 months
3. Objective response rate (ORR: CR + PR)
4. Disease control rate (DCR: CR + PR + SD)
5. Response duration (RD)
6. Overall survival (OS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who are 20 years old or above at the time of informed consent
2. Patients with the ECOG performance status of 0 to 2 at the time of informed consent
3. Patients with a life expectancy of at least 90 days from the day of enrollment
4. Patients with a measurable lesion defined by the criteria of the RECIST version 1.1 according to the imaging during screening period
5. Patients judged by the (sub)investigator for whom the treatment may be continued R-OKY-034F-101 study

Exclude criteria

1. Patients with active duplicate cancer
2. Patients with QTcE of over 500 msec
3. Patients weighing less than 40 kg at the time of informed consent
4. Patients who are considered inappropriate as a subject of this study by the (sub)investigator

Related Information

• Primary Sponsor: Kusaka Haruki