ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.

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Detailed Description

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Conditions

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Malignant Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort

Group Type EXPERIMENTAL

ONO-4538

Intervention Type BIOLOGICAL

1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Interventions

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ONO-4538

1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm.
* Tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists.
* ECOG Performance Status of 0-1
* Life expectancy ≥ 3 months

Exclusion Criteria

* History of severe hypersensitivity reactions to other antibodies.
* Residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator.
* Two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years.
* Patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No