Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT03182257

Run by

Ono Pharmaceutical Co., Ltd.

People needed

1

Starts

2017-07-12

Expected to finish

2018-01-30

Last updated by the study team

2019-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Radiotherapy within two weeks prior to study entry
• Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of study treatment
• 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
• 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.
• Concurrent treatment with another investigational agent or participated in another investigational trial within 30 days of study entry
• 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.
• 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
• 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
• Serious concurrent medical conditions, including serious active infection, in the opinion of the investigator
• Female patients who are pregnant or breast feeding

Where it is running

• 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
• Beatson West of Scotland Cancer Centre — Glasgow, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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