MedTrace Logo

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

NCT03934372 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ponatinib

Ponatinib administered as a tablet or age-appropriate formulation for pediatric participants according to age-based cohort assignment.

Sponsors & Collaborators

  • Incyte Biosciences International Sàrl

    lead INDUSTRY

Principal Investigators

  • Mohammed-El-Amine Bensmaine, MD · Incyte Biosciences International Sàrl

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2028-02-01
Completion
2028-02-01
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03934372 on ClinicalTrials.gov