DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.

ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility. PAEDIATRIC PATIENTS (<18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility. Patients with significant cardiovascular disease are excluded as defined by: i. Current congestive heart failure requiring therapy (NYHA III or IV) or known LVEF <50% (moderate to severe). ii. History of unstable angina pectoris or myocardial infarction up to three months prior to trial entry, or current poorly controlled angina (symptoms weekly or more). iii. Presence of symptomatic or severe valvular heart disease (severe by local echo graphic criteria or AHA/ACC Stage C or D). iv. History of a clinically significant cardiac arrhythmia up to three months prior to trial entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block are permitted). v. History of stroke (ischaemic or haemorrhagic) within the last three months. Patients with a baseline QTcF interval longer than 450 ms for male patients and 470 ms for female patients, patients with congenital long QTcF syndrome, and patients taking medicinal products that are known to prolong the QTc interval. History of additional risk factors for Torsades de Pointes (e.g., family history of long QT syndrome)