drugset / Trial / NCT01742286
Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors, with and without food.
Timeline
- Start
- 2013-08-28
- Primary completion
- 2019-04-26
- Completion
- 2019-04-26
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper The RDE of ceritinib was established as 510 mg/m2 (fasted) and 500 mg/m2 (fed). PMID 34780709 ↗
Publications
- Fischer M, Moreno L, Ziegler DS, Marshall LV, Zwaan CM, Irwin MS, Casanova M, Sabado C, Wulff B, Stegert M, Wang L, Hurtado FK, Branle F, Geoerger B, Schulte JH. Ceritinib in paediatric patients with anaplastic lymphoma kinase-positive malignancies: an open-label, multicentre, phase 1, dose-escalation and dose-expansion study. Lancet Oncol. 2021 Dec;22(12):1764-1776. doi: 10.1016/S1470-2045(21)00536-2. Epub 2021 Nov 12.
- Brivio E, Zwaan CM. ALK inhibition in two emblematic cases of pediatric inflammatory myofibroblastic tumor: Efficacy and side effects. Pediatr Blood Cancer. 2019 May;66(5):e27645. doi: 10.1002/pbc.27645. Epub 2019 Jan 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceritinib | Small molecule | 300 mg/m2 | Oral |
| Subject | Ceritinib | Small molecule | 320 mg/m2 | Oral |
| Subject | Ceritinib | Small molecule | 500 mg/m2 | Oral |
| Subject | Ceritinib | Small molecule | 510 mg/m2 | Oral |
Indications
No indication recorded.