ONO-4538 Phase I Study in Patients With Solid Tumor

• Sponsor: Ono Pharmaceutical Co. Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02261298
• Collaborator: (none)
• Enrollment: 18
• Locations: 5
• Arms: 3
• Actual Duration (Months): 66
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors; Recurrent Solid Tumors	Drug: ONO-4538	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Multiple Dose Study in Solid Tumor
• Actual Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ONO-4538 1mg/kg ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle	Drug: ONO-4538
Experimental: ONO-4538 3mg/kg ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle	Drug: ONO-4538
Experimental: ONO-4538 10mg/kg ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle	Drug: ONO-4538

Outcome Measures

Primary Outcome Measures

1. Safety outcome: The number of subjects with overall adverse events [Approximately 6 months]

2. Safety outcome: The number of deaths [Approximately 6 months]

3. PK outcome: Cmax of ONO-4538 [Approximately 10 months]

4. Efficacy outcome: Response rate [Approximately 6 months]

5. Efficacy outcome: Progression free survival [Approximately 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seongnam-si Clinical Site 105	Seongnam-si	Gyeonggi-do	Korea, Republic of
2	Seoul Clinical Site 101	Seoul		Korea, Republic of
3	Seoul Clinical Site 102	Seoul		Korea, Republic of
4	Seoul Clinical Site 103	Seoul		Korea, Republic of
5	Seoul Clinical Site 104	Seoul		Korea, Republic of

Sponsors and Collaborators

• Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Mitsunobu Tanimoto, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ono Pharmaceutical Co. Ltd
• ClinicalTrials.gov Identifier: NCT02261298
• Other Study ID Numbers: ONO-4538-14
• First Posted: Oct 10, 2014
• Last Update Posted: Mar 23, 2021
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Neoplasms; Nivolumab

Study Results

No Results Posted as of Mar 23, 2021