This study will determine the safety and maximum tolerated dose of ONO-7579 in patients with advanced solid tumors, and evaluate efficacy of ONO-7579 in patients with advanced solid tumors harboring NTRK gene fusions.
The trial was designed to be a Phase 1/2 trial, but was terminated without progressing to Phase 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
ONO-7579 Tablets
Montefiore Medical Center
Lake Success, New York, United States
Mount Sinai
New York, New York, United States
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
Part A: Incidence, nature and severity of Adverse Events
To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD
Time frame: up to 28 days
Part A: Clinically significant changes in physical examinations
To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD
Time frame: up to 28 days
Part A: Clinically significant changes in neurological examinations
To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD
Time frame: up to 28 days
Part A: Clinically significant changes in vital signs and electrocardiogram - including the evaluation of the QT interval
To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD
Time frame: up to 28 days
Part B: Overall Response Rate (ORR)
Assessed by Independent Central Review using RECIST 1.1 or RANO criteria
Time frame: up to 24 months
Part A and B Pharmacokinetics (Cmax)
Assessment of the maximum plasma concentration of ONO-7579
Time frame: Day 1, 2, 7, 14 and 28
Part A and B Pharmacokinetics (Tmax)
Assessment of the time to reach maximum observed plasma concentration of ONO-7579
Time frame: Day 1, 2, 7, 14 and 28
Part A and B Pharmacokinetics (AUC)
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Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Assessment of the plasma area under the curve from time zero to 24 hours after dosing
Time frame: Day 1, 2, 7, 14 and 28
Part A and B Pharmacokinetics (T1/2)
Assessment of the plasma decay half life of ONO-7579
Time frame: Day 1, 2, 7, 14 and 28
Part A and B Pharmacokinetics (Ctrough)
Assessment of the trough concentration of ONO-7579 in plasma
Time frame: Day 1, 2, 7, 14 and 28
Part A Overall Response Rate (ORR)
Assessed by investigator using RECIST 1.1 or RANO criteria
Time frame: up to 28 days
Part A Duration of Response (DoR)
Assessed by investigator using RECIST 1.1 or RANO criteria
Time frame: up to 28 days
Part A Progression Free Survival (PFS)
Assessed by investigator using RECIST 1.1 or RANO criteria
Time frame: up to 28 days
Part B Progression Free Survival (PFS)
Assessed by Independent Central Review using RECIST 1.1 or RANO criteria
Time frame: up to 24 months
Part B Overall Survival (OS)
Assessed by Independent Central Review using RECIST 1.1 or RANO criteria
Time frame: up to 24 months
Part B Time to Response (TTR)
Assessed by Independent Central Review using RECIST 1.1 or RANO criteria
Time frame: up to 24 months
Part B Time to Progression (TTP)
Assessed by Independent Central Review using RECIST 1.1 or RANO criteria
Time frame: up to 24 months
Part B Incidence, nature and severity of Adverse Events
To determine the safety and tolerability of ONO-7579
Time frame: up to 24 months
Part B: Clinically significant changes in physical examinations
To determine the safety and tolerability of ONO-7579
Time frame: up to 24 months
Part B: Clinically significant changes in neurological examinations
To determine the safety and tolerability of ONO-7579
Time frame: up to 24 months
Part B: Clinically significant changes in vital signs and electrocardiogram - including the evaluation of the QT interval
To determine the safety and tolerability of ONO-7579
Time frame: up to 24 months