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NCT03934372
Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to \< 18 years with advanced leukemias, lymphomas, and solid tumors.
Trial Details
NCT ID NCT03934372
Phase PHASE1 / PHASE2
Sponsor Incyte Biosciences International Sàrl
Status RECRUITING
Cancer Type Acute Lymphoblastic (ALL) Leukemia
Interventions
Locations (sample) Ghent, Belgium|51.05,3.71667 Paris, France|48.85341,2.3488 Paris, France|48.85341,2.3488 Poitiers, France|46.58261,0.34348 Rennes, France|48.11109,-1.67431
Key Eligibility Criteria
Histologically or cytologically confirmed diagnosis of the following malignancies: \- Phase 1: CP-CML, BP-CML, AP-CML ALL. AML. Other leukemias. Lymphoma. Any other tumors, including tumors of the CNS, for which standard therapy i… \- Phase 2, Group A with CP-CML: CP-CML at the time of study entry and must be resistant to or intolerant of at least 1 prior BCR-ABL-targeted TKI … Must have 1 bone marrow aspirate with documentation of BCR-ABL translocation by conventional cytogenetics, metaphase FISH, or q-PCR performed withi…
For full eligibility, visit ClinicalTrials.gov .