CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 83 enrolled
Drug / intervention
Ceritinibdrug
Likely dose
Ceritinib 30 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01742286
NCT01742286Phase 1Completed
CompareCT.gov

A Phase I, Open-label, Dose Escalation Study of LDK378 in Pediatric Patients With Malignancies That Have a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

Novartis Pharmaceuticals·interventional·Posted Dec 5, 2012·Updated Jun 9, 2020

In Brief

A Phase 1 clinical trial evaluating Ceritinib for ALK-activated Tumors. Completed, enrolled 83 participants across 23 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALK-activated Tumors
CountriesAustralia, Canada, France, Germany, Italy, Netherlands, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2012
Enrollment StartAug 28, 2013
Primary CompletionApr 26, 2019
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 13.6 years ago

Interventions

Ceritinibdrug

LDK378 is a capsule taken by mouth, contents can be mixed with food for pediatric patients or mixed with water and given via nasogastric/gastric (NG/G) tube. For patients in fasted group: 1-2 tablespoons (15-30 mL) of an appropriate food such as apple sauce or non-fat yogurt and a glass of water were allowed. For patients in the fed cohort: LDK378 was taken with, or within 30 minutes after finishing a low-fat light snack containing 100-300 calories and 1.5-2 grams of fat.