ONO-4538 Phase I Study in Patients With Solid Tumor

March 19, 2021 updated by: Ono Pharmaceutical Co. Ltd

ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Multiple Dose Study in Solid Tumor

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, 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
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of
        • Seongnam-si Clinical Site 105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-4538 1mg/kg
ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle
Drug: ONO-4538
Experimental: ONO-4538 3mg/kg
ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle
Drug: ONO-4538
Experimental: ONO-4538 10mg/kg
ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle
Drug: ONO-4538

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4538-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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