Ceritinib

Generic Name
Ceritinib
Brand Names
Zykadia
Drug Type
Small Molecule
Chemical Formula
C28H36ClN5O3S
CAS Number
1032900-25-6
Unique Ingredient Identifier
K418KG2GET
Background

Ceritinib is used for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) following failure (secondary to resistance or intolerance) of prior crizotinib therapy. About 4% of patients with NSCLC have a chromosomal rearrangement that generates a fusion gene between EML4 (echinoderm microtubule-as...

Indication

Ceritinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or...

Associated Conditions
Refractory, locally advanced Non small cell lung cancer, Refractory, metastatic Non small cell lung cancer
Associated Therapies
-

Next Generation Personalized Neuroblastoma Therapy

First Posted Date
2016-05-23
Last Posted Date
2023-11-29
Lead Sponsor
Yael P Mosse
Target Recruit Count
66
Registration Number
NCT02780128
Locations
🇺🇸

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma

First Posted Date
2016-04-06
Last Posted Date
2019-10-10
Lead Sponsor
University of Washington
Registration Number
NCT02729961
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies

First Posted Date
2015-12-23
Last Posted Date
2018-04-02
Lead Sponsor
Criterium, Inc.
Target Recruit Count
4
Registration Number
NCT02638909
Locations
🇺🇸

Yale University, Yale Cancer Center, New Haven, Connecticut, United States

🇺🇸

Swedish Cancer Institute, Seattle, Washington, United States

🇺🇸

University of Colorado Cancer Center, Aurora, Colorado, United States

and more 3 locations

Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study

Phase 4
Active, not recruiting
Conditions
Interventions
First Posted Date
2015-10-23
Last Posted Date
2024-11-27
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
234
Registration Number
NCT02584933
Locations
🇺🇸

Maryland Oncology Hematology P A, Rockville, Maryland, United States

🇺🇸

Essex Oncology of North Jersey PA, Belleville, New Jersey, United States

🇨🇳

Novartis Investigative Site, Taoyuan, Taiwan

and more 3 locations

Pediatric Precision Laboratory Advanced Neuroblastoma Therapy

First Posted Date
2015-09-24
Last Posted Date
2024-08-23
Lead Sponsor
Giselle Sholler
Target Recruit Count
500
Registration Number
NCT02559778
Locations
🇺🇸

Penn State Milton S. Hershey Medical Center and Children's Hospital, Hershey, Pennsylvania, United States

🇺🇸

St. Lukes, Boise, Idaho, United States

🇺🇸

Connecticut Children's Hospital, Hartford, Connecticut, United States

and more 23 locations

Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma

First Posted Date
2015-07-31
Last Posted Date
2023-02-03
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
14
Registration Number
NCT02513667
Locations
🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors

First Posted Date
2015-04-21
Last Posted Date
2020-12-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
33
Registration Number
NCT02422589
Locations
🇺🇸

Cancer Therapy & Research Center UT Health Science Center SC-4, San Antonio, Texas, United States

🇺🇸

Henry Ford Hospital SC, Detroit, Michigan, United States

🇺🇸

Karmanos Cancer Institute Oncology Department, Detroit, Michigan, United States

and more 1 locations

Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2015-01-22
Last Posted Date
2017-02-01
Lead Sponsor
Anne Beaven, MD
Registration Number
NCT02343679
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-01-13
Last Posted Date
2020-04-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
156
Registration Number
NCT02336451
Locations
🇺🇸

The Ohio State University Comprehensive Cancer Center Ohio State University, Columbus, Ohio, United States

🇺🇸

USC Kenneth Norris Comprehensive Cancer Center SC-3, Los Angeles, California, United States

🇺🇸

Dana Farber Cancer Institute SC-12, Boston, Massachusetts, United States

and more 6 locations
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