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Recruiting Phase 1, Phase 2 NCT06208657

Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

◆ AI Clinical Summary
Plain-language summary for patients

Trial Parameters

Condition Childhood Cancer
Sponsor Australian & New Zealand Children's Haematology/Oncology Group
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 90
Sex ALL
Min Age 0 Years
Max Age 21 Years
Start Date 2024-07-10
Completion 2030-12
Interventions
PaxalisibOpdualagIrinotecan (drug)

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Brief Summary

A companion platform trial to test novel targeted agents based on the patient's tumor profile.

Eligibility Criteria

Inclusion Criteria: 1. 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. 2. 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. 3. Patients must be enrolled on a precision medicine study (i.e. PROFYLE, ZERO or equivalent as agreed with Study Chair). 4. Patients enrolled in a Phase I cohort must have either evaluable or measurable disease. 5. Patients enrolled in a Phase II cohort must have measurable disease. Evaluable and measurable disease are defined by standard imaging criteria for the patient's tumor type. 6. Disease evaluations, laboratory tests, and other clinical assessments that are considered standard of care may be undertaken at the patient's local oncology treatment centre with results transferred to study site for evaluation. 7. Performance st

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