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 Study in Solid Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261285
• Other study ID #: ONO-4538-13
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Est. completion date: December 2014

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

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	PK Outcome: Cmax of ONO-4538	Cmax was the maximum serum concentration of ONO-4538 after the single administration.	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.
Primary	PK Outcome: Tmax of ONO-4538	Tmax was the time to reach the Cmax.	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.
Primary	AUC21day	AUC21day was the area under serum concentration-time curve of ONO-4538 from day 0 to day 21 (last measurement).	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.
Primary	AUCinf	AUCinf was the area under serum concentration-time curve of ONO-4538 extrapolated to infinity.	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.
Primary	T1/2	T1/2 was the elimination half-life of serum concentration of ONO-4538.	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.
Secondary	Safety Outcome: The Number of Subjects With Overall Adverse Events	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.	3 weeks: from the start of administration to the end of treatment phase.
Secondary	Safety Outcome: The Number of Deaths	Number of subjects with TEAEs leading to death.	3 weeks: from the start of administration to the end of treatment phase.