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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00836888
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : November 28, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Biological: ONO-4538 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cohort Biological: ONO-4538
1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Primary Outcome Measures :
  1. 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 ]
  2. 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 :
  1. Evaluation of pharmacodynamics [ Time Frame: up to study completion, every 4 weeks in principle ]
  2. Exploratory evaluation of efficacy (tumor response, tumor markers) [ Time Frame: up to study completion, every 4 weeks in principle ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00836888

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

Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT00836888     History of Changes
Other Study ID Numbers: ONO-4538-01
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: April 2015

Keywords provided by Ono Pharmaceutical Co. Ltd:
solid tumors

Additional relevant MeSH terms:
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs