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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00836888
First received: January 26, 2009
Last updated: January 16, 2013
Last verified: December 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • Evaluation of the pharmacokinetics [ Time Frame: up to study completion, each visit in principle after the second administration, more frequently at the first administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of pharmacodynamics [ Time Frame: up to study completion, every 4 weeks in principle ] [ Designated as safety issue: No ]
  • Exploratory evaluation of efficacy (tumor response, tumor markers) [ Time Frame: up to study completion, every 4 weeks in principle ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836888

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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00836888     History of Changes
Other Study ID Numbers: ONO-4538-01
Study First Received: January 26, 2009
Last Updated: January 16, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-4538
MDX-1106
solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013