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

Phase I / IIa, single-institution, open-label study to explore the safety and efficacy of R-OKY-034F long-term administration in patients with refractory / intolerable and surgically unresectable pancreatic cancer with standard chemotherapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051200105

Enrollment

Registered

2020-12-24

Start date

2019-09-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Adverse Event and Side Effect	—

Secondary

Measure	Time frame
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)	—

Contacts

Public ContactHaruki Kusaka

J-Pharma Co., Ltd.

kusaka.h@j-pharma.com+81-45-506-1155

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026