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Completed

NCT Number: NCT02261298

ONO-4538 Phase I Study in Patients With Solid Tumor

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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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

  • 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.

Treatment and study plan

ONO-4538

Drug

Primary outcomes

  1. Safety outcome: The number of subjects with overall adverse events

    Time frame: Approximately 6 months

  2. Safety outcome: The number of deaths

    Time frame: Approximately 6 months

  3. PK outcome: Cmax of ONO-4538

    Time frame: Approximately 10 months

  4. Efficacy outcome: Response rate

    Time frame: Approximately 6 months

  5. Efficacy outcome: Progression free survival

    Time frame: Approximately 6 months

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2020
First posted
Oct 10, 2014
Registry last updated
May 3, 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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