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
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms
• Recurrent Solid Tumors

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