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DRUG:
Zykadia (ceritinib)
i
Other names:
LDK378, NVP-LDK 378, NVP-LDK378-NX, LDK-378
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Associations
(67)
News
Trials
Company:
BeiGene, Novartis
Drug class:
ALK inhibitor
Related drugs:
‹
crizotinib (312)
entrectinib (178)
alectinib (104)
lorlatinib (94)
brigatinib (50)
ensartinib (42)
repotrectinib (27)
iruplinalkib (11)
TAE-684 (9)
SAF-189 (7)
unecritinib (6)
APG-2449 (4)
TPX-0131 (4)
envonalkib (3)
TGRX-326 (3)
AZD3463 (2)
NVL-655 (1)
SY-707 (1)
SY-3505 (1)
ALK inhibitor (0)
ASP-3026 (0)
CEP-37440 (0)
TY-2136b (0)
ZG0418 (0)
TSR-011 (0)
XZP-3621 (0)
crizotinib (312)
entrectinib (178)
alectinib (104)
lorlatinib (94)
brigatinib (50)
ensartinib (42)
repotrectinib (27)
iruplinalkib (11)
TAE-684 (9)
SAF-189 (7)
unecritinib (6)
APG-2449 (4)
TPX-0131 (4)
envonalkib (3)
TGRX-326 (3)
AZD3463 (2)
NVL-655 (1)
SY-707 (1)
SY-3505 (1)
ALK inhibitor (0)
ASP-3026 (0)
CEP-37440 (0)
TY-2136b (0)
ZG0418 (0)
TSR-011 (0)
XZP-3621 (0)
›
Associations
(67)
News
Trials
Phase
Status
Apply
Phase
Status
Apply
Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer (NCT02321501)
Phase 1
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Active, not recruiting
Phase 1
M.D. Anderson Cancer Center
Active, not recruiting
Last update posted :
06/10/2024
Initiation :
06/22/2016
Primary completion :
12/31/2024
Completion :
12/31/2024
ROS1
|
ALK positive • ROS1 rearrangement
|
everolimus • Zykadia (ceritinib)
Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (NRG-LU003) (NCT03737994)
Phase 2
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Active, not recruiting
Phase 2
National Cancer Institute (NCI)
Active, not recruiting
Last update posted :
06/07/2024
Initiation :
07/25/2019
Primary completion :
07/21/2021
Completion :
09/21/2024
MET
|
ALK positive • MET amplification • ALK rearrangement
|
cisplatin • Xalkori (crizotinib) • carboplatin • Alecensa (alectinib) • Lorbrena (lorlatinib) • Zykadia (ceritinib) • pemetrexed • Alunbrig (brigatinib) • Ensacove (ensartinib) • Pemfexy (pemetrexed)
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation (PIKACHU) (NCT04322890)
Phase 2
Hunan Province Tumor Hospital
Hunan Province Tumor Hospital
Recruiting
Phase 2
Hunan Province Tumor Hospital
Recruiting
Last update posted :
06/04/2024
Initiation :
04/16/2020
Primary completion :
12/24/2026
Completion :
12/24/2027
EGFR • BRAF • ALK • ROS1
|
EGFR mutation • ALK positive • ALK mutation • ROS1 positive • ROS1 mutation
|
cisplatin • Xalkori (crizotinib) • Tagrisso (osimertinib) • erlotinib • gefitinib • Rozlytrek (entrectinib) • Alecensa (alectinib) • Lorbrena (lorlatinib) • Zykadia (ceritinib) • pemetrexed • Alunbrig (brigatinib) • Gavreto (pralsetinib) • Ameile (aumolertinib) • Orpathys (savolitinib) • Ivesa (firmonertinib)
Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC (NCT03611738)
Phase 1
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Resear...
Active, not recruiting
Phase 1
H. Lee Moffitt Cancer Center and Research Insti...
Active, not recruiting
Last update posted :
05/08/2024
Initiation :
02/01/2019
Primary completion :
04/01/2025
Completion :
04/01/2025
PD-L1
|
docetaxel • Zykadia (ceritinib)
Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma (NCT03501368)
Phase 1
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Resear...
Active, not recruiting
Phase 1
H. Lee Moffitt Cancer Center and Research Insti...
Active, not recruiting
Last update posted :
04/30/2024
Initiation :
06/27/2018
Primary completion :
10/28/2022
Completion :
08/01/2024
PD-L1 • BRAF
|
BRAF mutation • BRAF V600
|
Mekinist (trametinib) • Zykadia (ceritinib)
Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (PEDS-PLAN) (NCT02559778)
Phase 2
Giselle Sholler
Giselle Sholler
Recruiting
Phase 2
Giselle Sholler
Recruiting
Last update posted :
04/08/2024
Initiation :
09/01/2015
Primary completion :
09/01/2030
Completion :
09/01/2035
MYCN
|
MYCN amplification
|
dasatinib • sorafenib • Zykadia (ceritinib) • Zolinza (vorinostat)
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma (NCT05489887)
Phase 2
Giselle Sholler
Giselle Sholler
Recruiting
Phase 2
Giselle Sholler
Recruiting
Last update posted :
04/08/2024
Initiation :
09/14/2022
Primary completion :
09/01/2026
Completion :
09/01/2033
MYCN
|
MYCN amplification
|
Zykadia (ceritinib) • Danyelza (naxitamab-gqgk)
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer (ASCEND-4) (NCT01828099)
Phase 3
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 3
Novartis Pharmaceuticals
Completed
Last update posted :
01/24/2024
Initiation :
07/09/2013
Primary completion :
06/24/2016
Completion :
01/07/2024
ALK
|
ALK positive
|
cisplatin • carboplatin • Zykadia (ceritinib) • pemetrexed
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib (NCT01828112)
Phase 3
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 3
Novartis Pharmaceuticals
Completed
Last update posted :
11/30/2023
Initiation :
06/28/2013
Primary completion :
01/26/2016
Completion :
11/10/2023
ALK
|
ALK positive
|
Xalkori (crizotinib) • docetaxel • Zykadia (ceritinib) • pemetrexed
A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib (ALTA-2) (NCT03535740)
Phase 2
Ariad Pharmaceuticals
Ariad Pharmaceuticals
Active, not recruiting
Phase 2
Ariad Pharmaceuticals
Active, not recruiting
Last update posted :
08/25/2023
Initiation :
01/31/2019
Primary completion :
09/30/2020
Completion :
06/28/2024
ALK
|
ALK rearrangement
|
Alecensa (alectinib) • Zykadia (ceritinib) • Alunbrig (brigatinib)
Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer (NCT02227940)
Phase 1
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Completed
Phase 1
Roswell Park Cancer Institute
Completed
Last update posted :
07/25/2022
Initiation :
01/08/2015
Primary completion :
12/27/2018
Completion :
02/12/2019
ALK
|
cisplatin • gemcitabine • Zykadia (ceritinib) • albumin-bound paclitaxel
Study of Safety and Preliminary Efficacy for LDK378 in Japanese Patients With Genetic Alterations in Anaplastic Lymphoma Kinase (ALK) (NCT01634763)
Phase 1
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 1
Novartis Pharmaceuticals
Completed
Last update posted :
12/19/2020
Initiation :
06/01/2012
Primary completion :
01/01/2016
Completion :
01/01/2016
ALK
|
ALK translocation
|
Zykadia (ceritinib)
Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer. (NCT02292550)
Phase 1
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 1
Novartis Pharmaceuticals
Completed
Last update posted :
12/17/2020
Initiation :
05/14/2015
Primary completion :
09/26/2018
Completion :
09/26/2018
ALK
|
ALK positive • ALK rearrangement
|
Zykadia (ceritinib) • Kisqali (ribociclib)
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 (NCT02276027)
Phase 2
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 2
Novartis Pharmaceuticals
Completed
Last update posted :
12/16/2020
Initiation :
01/20/2015
Primary completion :
10/15/2019
Completion :
10/15/2019
BRAF
|
Piqray (alpelisib) • Mektovi (binimetinib) • Zykadia (ceritinib) • Tabrecta (capmatinib) • luminespib (AUY922)
Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis (NCT02605746)
Phase 1
St. Joseph's Hospital and Medical Center, Phoenix
St. Joseph's Hospital and Medical Cente...
Completed
Phase 1
St. Joseph's Hospital and Medical Center, Phoenix
Completed
Last update posted :
12/11/2020
Initiation :
02/17/2016
Primary completion :
11/29/2018
Completion :
07/12/2019
CASP3
|
Zykadia (ceritinib)
Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) (NCT01742286)
Phase 1
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 1
Novartis Pharmaceuticals
Completed
Last update posted :
06/09/2020
Initiation :
08/28/2013
Primary completion :
04/26/2019
Completion :
04/26/2019
ALK
|
Zykadia (ceritinib)
Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma (NCT02729961)
Phase 1/2
University of Washington
University of Washington
Withdrawn
Phase 1/2
University of Washington
Withdrawn
Last update posted :
10/10/2019
Initiation :
01/03/2018
Primary completion :
07/01/2023
Completion :
07/01/2023
ALK
|
ALK positive
|
Zykadia (ceritinib) • Adcetris (brentuximab vedotin)
Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer (NCT02289144)
Phase 2
University of Texas Southwestern Medical Center
University of Texas Southwestern Medica...
Withdrawn
Phase 2
University of Texas Southwestern Medical Center
Withdrawn
Last update posted :
07/30/2019
Initiation :
06/01/2015
Primary completion :
01/01/2019
Completion :
01/01/2019
ALK
|
ALK mutation
|
Zykadia (ceritinib)
LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer (ASCEND-3) (NCT01685138)
Phase 2
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 2
Novartis Pharmaceuticals
Completed
Last update posted :
03/26/2019
Initiation :
12/20/2012
Primary completion :
01/22/2018
Completion :
01/22/2018
ALK
|
ALK rearrangement
|
Xalkori (crizotinib) • Zykadia (ceritinib)
A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (NCT01283516)
Phase 1
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 1
Novartis Pharmaceuticals
Completed
Last update posted :
03/15/2019
Initiation :
01/24/2011
Primary completion :
05/03/2016
Completion :
05/03/2016
ALK
|
ALK translocation
|
Zykadia (ceritinib)
LDK378 in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib (NCT02040870)
Phase 1/2
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 1/2
Novartis Pharmaceuticals
Completed
Last update posted :
02/20/2019
Initiation :
03/07/2014
Primary completion :
07/27/2017
Completion :
07/27/2017
ALK
|
ALK positive • ALK rearrangement
|
Xalkori (crizotinib) • Zykadia (ceritinib)
A Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement (NCT03399487)
Phase 2
Yonsei University
Yonsei University
Unknown status
Phase 2
Yonsei University
Unknown status
Last update posted :
01/11/2019
Initiation :
07/24/2018
Primary completion :
05/01/2020
Completion :
10/01/2020
BRAF • ROS1
|
ROS1 rearrangement
|
Zykadia (ceritinib)
An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement (NCT01964157)
Phase 2
Yonsei University
Yonsei University
Unknown status
Phase 2
Yonsei University
Unknown status
Last update posted :
01/11/2019
Initiation :
09/01/2013
Primary completion :
12/01/2019
Completion :
12/01/2019
ROS1
|
ROS1 rearrangement
|
Zykadia (ceritinib)
LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib (NCT01685060)
Phase 2
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 2
Novartis Pharmaceuticals
Completed
Last update posted :
06/19/2017
Initiation :
11/26/2012
Primary completion :
03/29/2016
Completion :
03/29/2016
ALK
|
ALK rearrangement
|
Xalkori (crizotinib) • Zykadia (ceritinib)
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