ONO-4538 Phase I Study in Patients With Solid Tumor

Phase 1

Completed

• Conditions: Advanced Solid Tumors; Recurrent Solid Tumors
• Interventions: Drug: ONO-4538

• Registration Number: NCT02261298
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-30
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-10
• Primary Completion: 2015-06
• Study Completion: 2020-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• The treatment phase has been completed in the ONO-4538-13 study

Exclusion Criteria

• The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study.
• It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-4538 1mg/kg	ONO-4538	ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle
ONO-4538 3mg/kg	ONO-4538	ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle
ONO-4538 10mg/kg	ONO-4538	ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle

Primary Outcome Measures

Name	Time	Method
Efficacy outcome: Response rate	Approximately 6 months
Efficacy outcome: Progression free survival	Approximately 6 months
Safety outcome: The number of subjects with overall adverse events	Approximately 6 months
PK outcome: Cmax of ONO-4538	Approximately 10 months
Safety outcome: The number of deaths	Approximately 6 months

Trial Locations

Locations (5)

Seongnam-si Clinical Site 105; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Seoul Clinical Site 101; 🇰🇷 Seoul, Korea, Republic of

Seoul Clinical Site 102; 🇰🇷 Seoul, Korea, Republic of

Seoul Clinical Site 103; 🇰🇷 Seoul, Korea, Republic of

Seoul Clinical Site 104; 🇰🇷 Seoul, Korea, Republic of