LDK378

DRUG12 trials

Sponsors

Novartis Pharmaceuticals, Yonsei University, National Health Research Institutes, Taiwan

Conditions

Adenocarcinoma Lung Cancer; Squamous Cell Lung CarcinomaAnaplastic Lymphoma Kinase (ALK)CholangiocarcinomaImpaired Hepatic FunctionNon-Small Cell Lung CancerNon-Small-Cell Lung CancerNon-small Cell Lung CancerNon-small Cell Lung Cancer (NSCLC)

Phase 1

A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase

CompletedNCT01283516

Novartis PharmaceuticalsTumors Characterized by Genetic Abnormalities of ALK

Start: 2011-01-24End: 2016-05-03Updated: 2019-03-15

Study of Safety and Preliminary Efficacy for LDK378 in Japanese Patients With Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)

CompletedNCT01634763

Novartis PharmaceuticalsTumors Characterized by Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)

Start: 2012-06-30End: 2016-01-31Updated: 2020-12-19

Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer

CompletedNCT01772797

Novartis PharmaceuticalsAnaplastic Lymphoma Kinase (ALK), Non-small Cell Lung Cancer

Start: 2013-06-30End: 2016-01-31Updated: 2020-12-19

Effect of Hepatic Impairment on LDK378 Pharmacokinetics

CompletedNCT01950481

Novartis PharmaceuticalsImpaired Hepatic Function, Normal Hepatic Function

Start: 2014-01-31End: 2016-09-30Updated: 2020-12-19

LDK378 in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib

CompletedNCT02040870

Novartis PharmaceuticalsNon-Small Cell Lung Cancer

Start: 2014-03-07End: 2017-07-27Updated: 2019-02-20

Phase 2

LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib

CompletedNCT01685060

Novartis PharmaceuticalsNon-Small Cell Lung Cancer

Start: 2012-11-26End: 2016-03-29Updated: 2017-06-19

LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer

CompletedNCT01685138

Novartis PharmaceuticalsNon-Small Cell Lung Cancer

Start: 2012-12-20End: 2018-01-22Updated: 2019-03-26

An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement

CompletedNCT01964157

Yonsei UniversityNon-small Cell Lung Cancer (NSCLC)

Start: 2013-09-01End: 2026-01-29Updated: 2026-07-14

A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer

CompletedNCT02276027

Novartis PharmaceuticalsAdenocarcinoma Lung Cancer; Squamous Cell Lung Carcinoma

Start: 2015-01-20End: 2019-10-15Updated: 2020-12-16

A Phase II Trial of LDK378 in ROS1 and /or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma

TerminatedNCT02374489

National Health Research Institutes, TaiwanCholangiocarcinoma

Start: 2015-03-31End: 2018-01-31Updated: 2018-04-05

LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.

CompletedNCT02450903

Novartis PharmaceuticalsNon-Small-Cell Lung Cancer

Start: 2015-08-21End: 2018-05-24Updated: 2021-03-30

Unknown Phase

Expanded Treatment Protocol With LDK378 in ALK(+) NSCLC

Novartis PharmaceuticalsNon-small Cell Lung Cancer (NSCLC)

Updated: 2020-11-03

Related Papers

Genetic landscape of patients with ALK-rearranged non-small-cell lung cancer (NSCLC) and response to ceritinib in ASCEND-1 study.

2021-11-2012 citations

Phase II study of ceritinib in alectinib‐pretreated patients with anaplastic lymphoma kinase‐rearranged metastatic non‐small‐cell lung cancer in Japan: <scp>ASCEND</scp>‐9

Cancer Science2018-06-3056 citations

Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5): Japanese subset

Japanese Journal of Clinical Oncology2018-01-3027 citations

Evaluating First-Line Ceritinib Therapy in ALK-Rearranged NSCLC Patients

Oncology Times2017-08-30

Co-amplification of <i>MET</i> and <i>PIK3CA</i> in NSCLC and data on a PDX mouse model.

Journal of Clinical Oncology2017-05-201 citations

Ceritinib in patients with advanced, crizotinib-treated, anaplastic lymphoma kinase-rearranged NSCLC: Japanese subset

Japanese Journal of Clinical Oncology2017-03-2413 citations

BMET-13. WHOLE BODY AND INTRACRANIAL EFFICACY OF CERITINIB IN ALK-INHIBITOR (ALKi)-NAIVE PATIENTS WITH ALK-REARRANGED (ALK+) NSCLC AND BASELINE BRAIN METASTASES (BM): RESULTS FROM ASCEND-1 AND -3

Neuro-Oncology2016-11-01

Cost-effectiveness of ceritinib in patients previously treated with crizotinib in anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer in Canada.

2016-05-2510 citations

Genetic landscape of ALK+ non-small cell lung cancer (NSCLC) patients (pts) and response to ceritinib in ASCEND-1.

Journal of Clinical Oncology2016-05-2016 citations

Whole body and intracranial efficacy of ceritinib in ALK-inhibitor (ALKi)-naive patients (pts) with ALK-rearranged (ALK+) NSCLC and baseline (BL) brain metastases (BM): Results from ASCEND-1 and -3.

Journal of Clinical Oncology2016-05-201 citations

Genomic profiling of lung adenocarcinoma patients reveals potential therapeutic targets when standard molecular testing is negative.

Journal of Clinical Oncology2016-05-20

Activity and safety of ceritinib in patients with ALK-rearranged non-small-cell lung cancer (ASCEND-1): updated results from the multicentre, open-label, phase 1 trial.

2016-03-11348 citations

Phase I Study of Ceritinib (LDK378) in Japanese Patients with Advanced, Anaplastic Lymphoma Kinase-Rearranged Non-Small-Cell Lung Cancer or Other Tumors.

2015-07-0156 citations

ASCEND-3: A single-arm, open-label, multicenter phase II study of ceritinib in ALKi-naïve adult patients (pts) with ALK-rearranged (ALK+) non-small cell lung cancer (NSCLC).

Journal of Clinical Oncology2015-05-2078 citations

ASCEND-2: A single-arm, open-label, multicenter phase II study of ceritinib in adult patients (pts) with ALK-rearranged (ALK+) non-small cell lung cancer (NSCLC) previously treated with chemotherapy and crizotinib (CRZ).

Journal of Clinical Oncology2015-05-2077 citations

Comparative efficacy of ceritinib and crizotinib in previously treated crizotinib-naïve anaplastic lymphoma kinase-positive (ALK+) advanced or metastatic non-small cell lung cancer (NSCLC): An adjusted indirect comparison.

Journal of Clinical Oncology2015-05-203 citations

Ceritinib in advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) non-small cell lung cancer (NSCLC): Results of the ASCEND-1 trial.

Journal of Clinical Oncology2014-05-2058 citations

Ceritinib in Asian versus Caucasian patients (Pts) with advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) NSCLC: Subgroup analysis of the ASCEND-1 trial.

Journal of Clinical Oncology2014-05-2012 citations

Ceritinib in <i>ALK</i> -Rearranged Non–Small-Cell Lung Cancer

New England Journal of Medicine2014-03-261466 citations