ONO-4538 Phase I Study in Patients With Solid Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Solid Tumors Recurrent Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

ONO-4538

Intervention Type DRUG

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

Group Type EXPERIMENTAL

ONO-4538

Intervention Type DRUG

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

Group Type EXPERIMENTAL

ONO-4538

Intervention Type DRUG

Interventions

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ONO-4538

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No