CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 156 enrolled
Drug / intervention
Ceritinibdrug
Likely dose
Ceritinib 750 mgfrom 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/NCT02336451
NCT02336451Phase 2Completed
CompareCT.gov

A Phase II, Multi-center, Open-label, Five-arm Study to Evaluate the Efficacy and Safety of Oral Ceritinib Treatment for Patients With ALK-positive Non-small Cell Lung Cancer (NSCLC) Metastatic to the Brain and/or to Leptomeninges

Novartis Pharmaceuticals·interventional·Posted Jan 13, 2015·Updated Apr 21, 2020

In Brief

A Phase 2 clinical trial evaluating Ceritinib for ALK-positive Non-small Cell Lung Cancer. Completed, enrolled 156 participants across 57 sites in 17 countries.

Detailed Summary

This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALK-positive Non-small Cell Lung Cancer
CountriesAustralia, Belgium, Brazil, Canada, France, Germany, Hong Kong, Italy, Netherlands, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 13, 2015
Enrollment StartApr 1, 2015
Primary CompletionFeb 6, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.5 years ago

Interventions

Ceritinibdrug

LDK378 is a gelatin capsule, administered orally once daily at a dose of 750 mg (five 150 mg capsules) on a continuous dosing schedule on an empty stomach.