ONO-4538 Phase I Study in Patients With Solid Tumor

NCT02261285 | Completed Phase 1 Results

• 1 other identifier: ONO-4538-13
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Advanced Solid Tumors; Recurrent Solid Tumors

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (2)

• Safety Outcome: The Number of Subjects With Overall Adverse Events

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

• Safety Outcome: The Number of Deaths

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

Study Arms (3)

ONO-4538 1mg/kg

EXPERIMENTAL

ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose

Drug: ONO-4538

ONO-4538 3mg/kg

EXPERIMENTAL

ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose

Drug: ONO-4538

ONO-4538 10mg/kg

EXPERIMENTAL

ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose

Drug: ONO-4538

Interventions

ONO-4538 DRUG

ONO-4538 10mg/kg; ONO-4538 1mg/kg; ONO-4538 3mg/kg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (5)

Seongnam-si Clinical Site 105

Seongnam-si, Gyeonggi-do, South Korea

Location

Seoul Clinical Site 101

Seoul, South Korea

Location

Seoul Clinical Site 102

Seoul, South Korea

Location

Seoul Clinical Site 103

Seoul, South Korea

Location

Seoul Clinical Site 104

Seoul, South Korea

Location

Related Publications (1)

• Lee KW, Lee DH, Kang JH, Park JO, Kim SH, Hong YS, Kim ST, Oh DY, Bang YJ. Phase I Pharmacokinetic Study of Nivolumab in Korean Patients with Advanced Solid Tumors. Oncologist. 2018 Feb;23(2):155-e17. doi: 10.1634/theoncologist.2017-0528. Epub 2017 Nov 20.

  PMID: 29158363 DERIVED

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Information Center
• Organization: Ono Pharmaceutical Co., Ltd.

clinical_trial@ono-pharma.com

Study Officials

• Mitsunobu Tanimoto

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Increase the dose sequentially.

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 10, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 6, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)