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

Phase 1

Recruiting

• Conditions: Pancreatic cancer

• Registration Number: JPRN-jRCT2051200105
• Lead Sponsor: Kusaka Haruki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Event and Side Effect

Secondary Outcome Measures

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