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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 : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Tracking Information
First Submitted Date  ICMJE March 17, 2017
First Posted Date  ICMJE May 16, 2017
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE April 10, 2017
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
  • Maximum observed serum concentration(Cmax) [ Time Frame: Up to Cycle 1 (each cycle is 28 days) ]
  • Area Under the blood concentration-time Curve(AUC) [ Time Frame: Up to Cycle 1 (each cycle is 28 days) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced or Metastatic Solid Tumors
Intervention  ICMJE
  • Drug: ONO-4578
    ONO-4578 specified dose on specified days
  • Drug: ONO-4538
    ONO-4538 specified dose on specified days
Study Arms  ICMJE
  • Experimental: Part A (Dose Escalation Part): ONO-4578 monotherapy
    ONO-4578 specified dose on specified days in advanced or metastatic solid tumors
    Intervention: Drug: ONO-4578
  • 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
    Interventions:
    • Drug: ONO-4578
    • Drug: ONO-4538
  • 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
    Interventions:
    • Drug: ONO-4578
    • Drug: ONO-4538
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2020)
138
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2017)
54
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ono Pharmaceutical Co. Ltd Medicine counseling department clinical_trial@ono.co.jp
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03155061
Other Study ID Numbers  ICMJE ONO-4578-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ono Pharmaceutical Co. Ltd
Study Sponsor  ICMJE Ono Pharmaceutical Co. Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maki Kondou Ono Pharmaceutical Co. Ltd
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP