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

NCT00836888 | Completed Phase 1 Results

• 1 other identifier: ONO-4538-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Tumor

Keywords

ONO-4538; MDX-1106; solid tumors

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Ceoi at Multiple Doses

  Ceoi：Serum concentrations immediately after the end of continuous administration

  day 15

Secondary Outcomes (1)

• Best Overall Response

  up to study completion, every 4 weeks in principle

Study Arms (1)

Cohort

EXPERIMENTAL

Biological: ONO-4538

Interventions

ONO-4538 BIOLOGICAL

1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Cohort

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (1)

Unknown Facility

Kanto Region, Kanto, Japan

Location

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: Ohyama Yukiya
• Organization: Ono Pharmaceutical Co. Ltd

y.ohyama@ono.co.jp

Study Officials

• Ohyama Yukiya

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: February 4, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2010
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2015-04

Locations

JP (1)