ClinicaliQ Trial Snapshot
- Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors — Recruiting • Phase I • Oncology • NCT03934372.
- What is being tested: Ponatinib, a tyrosine kinase inhibitor, is being evaluated for safety, tolerability, pharmacokinetics, and efficacy in paediatric patients aged 1-18 years with recurrent or refractory leukemias, lymphomas, and solid tumors.
- Patient eligibility overview: The trial enrolls children aged 1 to less than 18 years with advanced haematologic malignancies (leukemias and lymphomas) or solid tumors that have recurred or are refractory to standard treatments.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : 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 is not available or is not indicated. - 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 therapy or be in "warning" response status or have the T315I kinase domain mutation. Must have 1 bone marrow aspirate with documentation of BCR-ABL translocation by conventional cytogenetics, metaphase FISH, or q-PCR performed within 42 days before the first dose of ponatinib. - Phase 2, Group B with other leukemias or solid tumors: ALL. AML. Other leukemias. Lymphoma. Any other tumors, including tumors of the CNS, with mutations of RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity (eg, EPH receptors and SRC families of kinases) as assessed on fresh or archived tumor tissue. Participants with solid tumors or with lymphoma must have measurable disease by CT or MRI based on RECIST v1.1 or the Lugano lymphoma guidelines as determined by site radiology.…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.