Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors
- Registration Number
- NCT03182257
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
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.
- Detailed Description
The trial was designed to be a Phase 1/2 trial, but was terminated without progressing to Phase 2.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Not provided
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Radiotherapy within two weeks prior to study entry
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Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of study treatment
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Spinal cord compression or brain metastases unless treated and radiologically stable for >6 weeks post treatment and not requiring steroids for at least 4 weeks prior to start of study treatment
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As judged by the Investigator, any evidence of severe or uncontrolled psychiatric disease or systemic diseases, including history of suicide attempt or current suicidal ideation or behavior, active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
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Concurrent treatment with another investigational agent or participated in another investigational trial within 30 days of study entry
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Diagnosed or treated for a malignancy other than the tumor under investigation in the study within 5 years, or who were previously diagnosed with a malignancy other than that required for the study and have any radiographic or biochemical marker evidence of that malignancy. Patients with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded.
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Clinically significant cardiovascular disease, including:
- History of myocardial infarction, acute coronary syndromes (including unstable angina), or coronary angioplasty/stenting/bypass grafting within the past 6 months.
- History of Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
- Severe cardiac arrhythmia requiring medication or other severe conduction abnormalities (e.g. clinically significant QT prolongation or Torsade de pointes)
- Uncontrolled hypertension
- Clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, or cardiomyopathy
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QT prolongation defined as a QTcF interval >470 msec or other significant ECG abnormalities including 2nd degree (type II) or 3rd degree AV block or bradycardia (ventricular rate <50 beats/min) on 12-lead ECG at screening
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Serious concurrent medical conditions, including serious active infection, in the opinion of the investigator
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Female patients who are pregnant or breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ONO-7579 Part A ONO-7579 Single Ascending doses of ONO-7579 ONO-7579 Part B ONO-7579 Expansion phase of ONO-7579
- Primary Outcome Measures
Name Time Method Part A: Clinically significant changes in vital signs and electrocardiogram - including the evaluation of the QT interval up to 28 days To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD
Part A: Clinically significant changes in neurological examinations up to 28 days To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD
Part A: Incidence, nature and severity of Adverse Events up to 28 days To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD
Part A: Clinically significant changes in physical examinations up to 28 days To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD
Part B: Overall Response Rate (ORR) up to 24 months Assessed by Independent Central Review using RECIST 1.1 or RANO criteria
- Secondary Outcome Measures
Name Time Method Part A and B Pharmacokinetics (Tmax) Day 1, 2, 7, 14 and 28 Assessment of the time to reach maximum observed plasma concentration of ONO-7579
Part A and B Pharmacokinetics (AUC) Day 1, 2, 7, 14 and 28 Assessment of the plasma area under the curve from time zero to 24 hours after dosing
Part A Duration of Response (DoR) up to 28 days Assessed by investigator using RECIST 1.1 or RANO criteria
Part A and B Pharmacokinetics (Cmax) Day 1, 2, 7, 14 and 28 Assessment of the maximum plasma concentration of ONO-7579
Part A and B Pharmacokinetics (Ctrough) Day 1, 2, 7, 14 and 28 Assessment of the trough concentration of ONO-7579 in plasma
Part B Overall Survival (OS) up to 24 months Assessed by Independent Central Review using RECIST 1.1 or RANO criteria
Part B Time to Progression (TTP) up to 24 months Assessed by Independent Central Review using RECIST 1.1 or RANO criteria
Part B Incidence, nature and severity of Adverse Events up to 24 months To determine the safety and tolerability of ONO-7579
Part B: Clinically significant changes in neurological examinations up to 24 months To determine the safety and tolerability of ONO-7579
Part A and B Pharmacokinetics (T1/2) Day 1, 2, 7, 14 and 28 Assessment of the plasma decay half life of ONO-7579
Part A Overall Response Rate (ORR) up to 28 days Assessed by investigator using RECIST 1.1 or RANO criteria
Part A Progression Free Survival (PFS) up to 28 days Assessed by investigator using RECIST 1.1 or RANO criteria
Part B Time to Response (TTR) up to 24 months Assessed by Independent Central Review using RECIST 1.1 or RANO criteria
Part B: Clinically significant changes in physical examinations up to 24 months To determine the safety and tolerability of ONO-7579
Part B Progression Free Survival (PFS) up to 24 months Assessed by Independent Central Review using RECIST 1.1 or RANO criteria
Part B: Clinically significant changes in vital signs and electrocardiogram - including the evaluation of the QT interval up to 24 months To determine the safety and tolerability of ONO-7579
Trial Locations
- Locations (5)
Greenville Hospital System University Medical Center
🇺🇸Greenville, South Carolina, United States
Mount Sinai
🇺🇸New York, New York, United States
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Mary Crowley Cancer Research Center
🇺🇸Dallas, Texas, United States
Montefiore Medical Center
🇺🇸Lake Success, New York, United States