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NCT02261298 Clinical Trial

ONO-4538 Phase I Study in Patients With Solid Tumor

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02261298
Other study ID # ONO-4538-14
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2014
Est. completion date April 2020

Study information
Verified date May 2024
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date April 2020
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-4538

Locations
Country Name City State
Korea, Republic of Seongnam-si Clinical Site 105 Seongnam-si Gyeonggi-do
Korea, Republic of Seoul Clinical Site 101 Seoul
Korea, Republic of Seoul Clinical Site 102 Seoul
Korea, Republic of Seoul Clinical Site 103 Seoul
Korea, Republic of Seoul Clinical Site 104 Seoul

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety outcome: The number of subjects with overall adverse events Approximately 6 months
Primary Safety outcome: The number of deaths Approximately 6 months
Primary PK outcome: Cmax of ONO-4538 Approximately 10 months
Primary Efficacy outcome: Response rate Approximately 6 months
Primary Efficacy outcome: Progression free survival Approximately 6 months
See also
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