Symptoms and General Pathology

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Recurrence

Antineoplastic Agents

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Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose

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

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

ONO-4538

Mitsunobu Tanimoto

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.

ONO-4538 Phase I Study in Patients With Solid Tumor

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

Cmax was the maximum serum concentration of ONO-4538 after the single administration.

AUC21day was the area under serum concentration-time curve of ONO-4538 from day 0 to day 21 (last measurement).

AUCinf was the area under serum concentration-time curve of ONO-4538 extrapolated to infinity.

T1/2 was the elimination half-life of serum concentration of ONO-4538.

Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following exposure to investigational product.

Number of subjects with TEAEs leading to death.

Ono Pharmaceutical Co. Ltd

Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.

ONO-4538 1 mg/kg

ONO-4538 3 mg/kg

ONO-4538 10 mg/kg

Total

Age, Continuous

<65 years

>=65-<75 years

>=75 years

Age, Customized

Sex: Female, Male

South Korea

Region of Enrollment

Height

Weight

PS 0 means "fully active, able to carry on all pre-disease performance without restriction" whereas PS 1 means "restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work". Please use the Measure Description to specify how participants were "staged" or "graded" clinically (e.g., briefly describe the criteria for the Rows or Categories) and specify which "stages" or "grades" were considered better or worse outcomes.

Performance status (Eastern Cooperative Oncology Group)

Type of primary cancer

History of surgery

History of radiotherapy

History of chemotherapy

Medical Information Center

PK Outcome: Cmax of ONO-4538

PK Outcome: Tmax of ONO-4538

AUC21day

AUCinf

T1/2

Safety Outcome: The Number of Subjects With Overall Adverse Events

Safety Outcome: The Number of Deaths

Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 1 mg/kg as an intravenous infusion over approximately 60 minutes.

Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 3 mg/kg as an intravenous infusion over approximately 60 minutes.

Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 10 mg/kg as an intravenous infusion over approximately 60 minutes.

Spots Global Cancer Trial Database for ONO-4538 Phase I Study in Patients With Solid Tumor

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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