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
  • Ponatinib
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.

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