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Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03155061
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Brief Summary:
The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Drug: ONO-4578 Drug: ONO-4538 Phase 1

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Study Type : Interventional
Estimated Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Part A (Dose Escalation Part): ONO-4578 monotherapy
ONO-4578 specified dose on specified days in advanced or metastatic solid tumors
Drug: ONO-4578
ONO-4578 specified dose on specified days

Experimental: Part B: ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors
Drug: ONO-4578
ONO-4578 specified dose on specified days

Drug: ONO-4538
ONO-4538 specified dose on specified days

Experimental: Part C (Expansion Part): ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer
Drug: ONO-4578
ONO-4578 specified dose on specified days

Drug: ONO-4538
ONO-4538 specified dose on specified days




Primary Outcome Measures :
  1. Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status) [ Time Frame: Through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Maximum observed serum concentration(Cmax) [ Time Frame: Up to Cycle 1 (each cycle is 28 days) ]
  2. Area Under the blood concentration-time Curve(AUC) [ Time Frame: Up to Cycle 1 (each cycle is 28 days) ]
  3. Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538 [ Time Frame: Up to Cycle 1 (each cycle is 28 days) ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Advanced or metastatic solid tumors (Part A, B)
  • Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
  • Life expectancy of at least 3 months
  • Patients with ECOG performance status 0 or 1

Exclusion Criteria:

  • Patients with severe complication
  • Patients with multiple primary cancers

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 ClinicalTrials.gov identifier (NCT number): NCT03155061


Contacts
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Contact: Ono Pharmaceutical Co. Ltd Corporate Communications +81-6-6263-5670 y.tani@ono.co.jp

Locations
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Japan
Tokyo Clinical Site Recruiting
Tokyo, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Maki Kondou Ono Pharmaceutical Co. Ltd

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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT03155061    
Other Study ID Numbers: ONO-4578-01
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents