CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
LDK378drug
Likely dose
LDK378 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/NCT02040870
NCT02040870Phase 2Completed
CompareCT.gov

A Phase I/II, Multicenter, Open-label, Single-arm Study of LDK378, Administered Orally in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib Study Type: Interventional

Novartis Pharmaceuticals·interventional·Posted Jan 20, 2014·Updated Feb 20, 2019

In Brief

A Phase 2 clinical trial evaluating LDK378 for Non-Small Cell Lung Cancer. Completed, enrolled 103 participants across 15 sites.

Detailed Summary

A single-Arm, open-label, multi-center, phase I/II study in which the pharmacokinetics, safety, tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with locally advanced or metastatic NSCLC harboring a confirmed ALK rearrangement. Patients must have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy. Approximately 100 patients will be enrolled. For the first 15 patients enrolled in this study, patients will have an additional 5-day PK run-in period before treatment period. The pharmacokinetics profile of LDK378 in Chinese adult patients with ALK-rearranged NSCLC will be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 20, 2014
Enrollment StartMar 7, 2014
Primary CompletionJul 27, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12.5 years ago

Interventions

LDK378drug

750 mg once daily