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

This study has been completed.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd Identifier:
First received: January 26, 2009
Last updated: November 24, 2016
Last verified: April 2015
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.

Condition Intervention Phase
Malignant Solid Tumor
Biological: ONO-4538
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors

Resource links provided by NLM:

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Evaluation of the safety (adverse event, clinical laboratory test, vital sign measurement, 12-lead electrocardiography, chest X-ray, ECOG performance status) [ Time Frame: Up to study completion, every 2 weeks in principle ]
  • Evaluation of the pharmacokinetics [ Time Frame: up to study completion, each visit in principle after the second administration, more frequently at the first administration ]

Secondary Outcome Measures:
  • Evaluation of pharmacodynamics [ Time Frame: up to study completion, every 4 weeks in principle ]
  • Exploratory evaluation of efficacy (tumor response, tumor markers) [ Time Frame: up to study completion, every 4 weeks in principle ]

Enrollment: 17
Study Start Date: January 2009
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort Biological: ONO-4538
1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00836888

Kanto Region, Kanto, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Study Director: Ohyama Yukiya Ono Pharmaceutical Co. Ltd
  More Information

Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT00836888     History of Changes
Other Study ID Numbers: ONO-4538-01
Study First Received: January 26, 2009
Last Updated: November 24, 2016

Keywords provided by Ono Pharmaceutical Co. Ltd:
solid tumors

Additional relevant MeSH terms:
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017