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Completed

NCT Number: NCT02261285

ONO-4538 Phase I Study in Patients With Solid Tumor

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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Key information

Conditions

Advanced Solid Tumors Recurrent Solid Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seongnam-si Clinical Site 105, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Current or prior severe hypersensitivity to another antibody product
  • Multiple primary cancers

Treatment and study plan

ONO-4538

Drug

Primary outcomes

  1. PK Outcome: Cmax of ONO-4538

    Time frame: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.

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

  2. PK Outcome: Tmax of ONO-4538

    Time frame: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.

    Tmax was the time to reach the Cmax.

  3. AUC21day

    Time frame: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.

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

  4. AUCinf

    Time frame: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.

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

  5. T1/2

    Time frame: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.

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

Secondary outcomes

  1. Safety Outcome: The Number of Subjects With Overall Adverse Events

    Time frame: 3 weeks: from the start of administration to the end of treatment phase.

    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.

  2. Safety Outcome: The Number of Deaths

    Time frame: 3 weeks: from the start of administration to the end of treatment phase.

    Number of subjects with TEAEs leading to death.

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2014
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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