ONO-4538 Phase I Study in Patients With Solid Tumor

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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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

2014-12-31

Brief Summary

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The objective of the study is to investigate the pharmacokinetics 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

SEQUENTIAL

Increase the dose sequentially.

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, single dose

Group Type EXPERIMENTAL

ONO-4538

Intervention Type DRUG

ONO-4538 3mg/kg

ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose

Group Type EXPERIMENTAL

ONO-4538

Intervention Type DRUG

ONO-4538 10mg/kg

ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose

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

* Male or female ≥ 20 years of age
* Histologically or cytologically confirmed solid tumor
* Patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available
* ECOG Performance Status is 0 to 1