Trials / Recruiting
RecruitingNCT03934372
Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors
An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors in Pediatric Participants
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Incyte Biosciences International Sàrl · Industry
- Sex
- All
- Age
- 1 Year – 17 Years
- Healthy volunteers
- Not accepted
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
- Acute Myeloid Leukemia
- Accelerated Phase Chronic Myeloid Leukemia
- Blast Phase Chronic Myeloid Leukemia
- Chronic Phase Chronic Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Acute Lymphocytic Leukemia
- Leukemia
- Lymphoma
- Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ponatinib | Ponatinib administered as a tablet or age-appropriate formulation for pediatric participants according to age-based cohort assignment. |
Timeline
- Start date
- 2020-01-29
- Primary completion
- 2028-02-01
- Completion
- 2028-02-01
- First posted
- 2019-05-01
- Last updated
- 2026-04-16
Locations
23 sites across 7 countries: Belgium, France, Italy, Netherlands, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03934372. Inclusion in this directory is not an endorsement.