Health Trials

Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors

ConditionsAcute Myeloid LeukemiaAccelerated Phase Chronic Myeloid LeukemiaBlast Phase Chronic Myeloid LeukemiaChronic Phase Chronic Myeloid LeukemiaAcute Lymphoblastic LeukemiaAcute Lymphocytic LeukemiaLeukemiaLymphomaSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-17
SponsorIncyte Biosciences International Sàrl

About this trial

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 criteria

Qualifiers

Karnofsky performance status ≥ 40% for participants ≥ 16 years old or Lansky Play Scale ≥ 40% for pediatric participants < 16 years old.

Participants must have recovered to < Grade 2 per the NCI CTCAE v5.0 or to baseline from any non-hematologic toxicities (except alopecia) due to previous therapy.

Willingness to avoid pregnancy or fathering children.

Disqualifiers

Immunosuppressive therapy (including post stem cell transplant regimens) within 14 days before the first dose of ponatinib.

Any targeted cancer therapy (including TKIs) within 7 days before the first dose of ponatinib.

Any other investigational anticancer agents within 30 days or 5 half-lives, whichever is longer, before randomization.

Any monoclonal antibody-directed anticancer therapy within 5 half-lives of the first dose of ponatinib.

Trial design

Treatments tested in this trial

  • Ponatinib

Treatment groups

70 Participants
are divided into 1 treatment group

Sponsors and collaborators

Incyte Biosciences International Sàrl

Lead sponsor

Source ClinicalTrials.gov