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
- -
Ceritinib and Everolimus in Treating Patients with Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2014-12-22
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 37
- Registration Number
- NCT02321501
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)
- First Posted Date
- 2014-11-24
- Last Posted Date
- 2022-02-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 306
- Registration Number
- NCT02299505
- Locations
- 🇺🇸
Goshen Center for Cancer Care IU Health - SC, Indianapolis, Indiana, United States
🇺🇸Loma Linda University, Loma Linda, California, United States
🇺🇸Utah Cancer Specialists Dept.of Utah Cancer Spec. (3), Salt Lake City, Utah, United States
Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.
- First Posted Date
- 2014-11-17
- Last Posted Date
- 2020-12-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 27
- Registration Number
- NCT02292550
- Locations
- 🇨🇳
Novartis Investigative Site, Taipei, Taiwan
Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer
- Conditions
- Interventions
- First Posted Date
- 2014-11-13
- Last Posted Date
- 2019-07-30
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Registration Number
- NCT02289144
- Locations
- 🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States
Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Interventions
- First Posted Date
- 2014-08-28
- Last Posted Date
- 2022-07-25
- Lead Sponsor
- Roswell Park Cancer Institute
- Target Recruit Count
- 38
- Registration Number
- NCT02227940
- Locations
- 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
- First Posted Date
- 2014-07-10
- Last Posted Date
- 2021-04-08
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 47
- Registration Number
- NCT02186821
- Locations
- 🇺🇸
Columbus Hematology and Oncology PA Columbus Hem and Onc (2), Columbus, Ohio, United States
🇺🇸MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3), Houston, Texas, United States
🇺🇸Swedish Cancer Institute Swedish Cancer Institute, Seattle, Washington, United States
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2013-04-10
- Last Posted Date
- 2024-01-24
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 376
- Registration Number
- NCT01828099
- Locations
- 🇬🇧
Novartis Investigative Site, Manchester, United Kingdom
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
- Conditions
- Interventions
- First Posted Date
- 2013-04-10
- Last Posted Date
- 2023-11-30
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 231
- Registration Number
- NCT01828112
- Locations
- 🇬🇧
Novartis Investigative Site, London, United Kingdom
Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)
- First Posted Date
- 2012-12-05
- Last Posted Date
- 2020-06-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 83
- Registration Number
- NCT01742286
- Locations
- 🇺🇸
Dana Farber Cancer Institute Dept of Onc, Boston, Massachusetts, United States
🇺🇸Memorial Sloan Kettering SC - 7, New York, New York, United States
🇬🇧Novartis Investigative Site, Sutton, Surrey, United Kingdom
Drug Development Updates
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