ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

Phase 1

Completed

• Conditions: Malignant Solid Tumor
• Interventions: Biological: ONO-4538

• Registration Number: NCT00836888
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Primary Completion: 2010-09
• Status Verified: 2015-04
• Results First Submitted: 2020-07-01
• Results First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Results First Posted: 2020-10-08
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm.
• Tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists.
• ECOG Performance Status of 0-1
• Life expectancy ≥ 3 months
• Other inclusion criteria as specified in the study protocol

Exclusion Criteria

• History of severe hypersensitivity reactions to other antibodies.
• Residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator.
• Two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years.
• Patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications.
• Other exclusion criteria as specified in the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	ONO-4538	-

Primary Outcome Measures

Name	Time	Method
Cmax at Single Dose	day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
AUClast at Single Dose	day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
Ceoi at Multiple Doses	day 15	Ceoi：Serum concentrations immediately after the end of continuous administration
T1/2 at Single Dose	day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation

Secondary Outcome Measures

Name	Time	Method
Best Overall Response	up to study completion, every 4 weeks in principle	Response Evaluation Criteria In Solid Tumors Criteria (ver 1.0) was used for this Outcome Measure.; Please see the reference for the detailed description. Therasse, Arbuck et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.