A companion platform trial to test novel targeted agents based on the patient's tumor profile.
Patients must be diagnosed with a solid tumor, CNS tumor or lymphoma that has progressed despite standard therapy, or for which no effective standard therapy exists.
Age <21 years at inclusion; patients 21 years and older may be included after approval by the Study Chair if they have a pediatric type recurrent/refractory malignancy.
Patients must be enrolled on a precision medicine study (i.e. PROFYLE, ZERO or equivalent as agreed with Study Chair).
Patients enrolled in a Phase I cohort must have either evaluable or measurable disease.
Patients with symptomatic central nervous system (CNS) primary or metastatic tumours who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease. Patients on stable doses of corticosteroids for at least 7 days prior to receiving study drug may be included.
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, or malabsorption syndrome) - only for arms that include orally administered therapeutic agents.
Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality), unstable ischemia, congestive heart failure within 12 months of screening.
Known active viral hepatitis or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
Australian & New Zealand Children's Haematology/Oncology Group
Lead sponsor
The Hospital for Sick Children
Collaborator
Medical Research Future Fund
Collaborator
Kazia Therapeutics Limited
Collaborator
C17 Council
Collaborator
Bristol-Myers Squibb
Collaborator
Stand Up To Cancer
Collaborator