Ceritinib
Information
- Drug Name
- Ceritinib
- Description
- Entry(CIViC)
- 17
CIViC
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| Updated results from ASCEND-1 trial assessing safe... | ALK | ALK ALK FUSIONS ALK ALK FUSIONS | Sensitivity | true | CIViC Evidence | detail |
| In a phase 1 clinical trial (NCT01283516) 130 pati... | ALK | ALK MUTATION ALK MUTATION | Sensitivity | true | CIViC Evidence | detail |
| Case report of a 77-year old male patient with lun... | ROS1 | ROS1 REARRANGEMENT ROS1 REARRANGEMENT | Sensitivity | true | CIViC Evidence | detail |
| Preclinical study analyzing the efficacy of dual R... | ROS1 | ROS1 CD74-ROS1 G2032R | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| The MGH056-1 cell line was derived from an NSCLC p... | ALK | ALK p.Ile1171Thr (p.I1171T) ALK p.Ile1171Thr (p.I1171T) | Sensitivity | true | CIViC Evidence | detail |
| Passaging of the alectinib sensitive EML4-ALK cont... | ALK | ALK EML4-ALK V1180L | Sensitivity | true | CIViC Evidence | detail |
| A 52 year old male never smoker was diagnosed with... | ALK | ALK p.Phe1245Cys (p.F1245C) ALK p.Phe1245Cys (p.F1245C) | Sensitivity | true | CIViC Evidence | detail |
| Ceritinib was 28x more potent (GI50 3.8nM) than cr... | ALK | ALK EML4-ALK E6;A20 | Sensitivity | true | CIViC Evidence | detail |
| The crizotinib-resistant MGH045 cell line with EML... | ALK | ALK EML4-ALK L1196M | Sensitivity | true | CIViC Evidence | detail |
| The NSCLC cell line MGH021-4, harboring SQSTM1-ALK... | ALK | ALK p.Gly1269Ala (p.G1269A) ALK p.Gly1269Ala (p.G1269A) | Sensitivity | true | CIViC Evidence | detail |
| Ba/F3 cells expressing the EML4-ALK S1206Y variant... | ALK | ALK EML4-ALK S1206Y | Sensitivity | true | CIViC Evidence | detail |
| Ba/F3 cells expressing EML4-ALK variant 3 with ALK... | ALK | ALK p.Ile1171Thr (p.I1171T) ALK p.Ile1171Thr (p.I1171T) | Sensitivity | true | CIViC Evidence | detail |
| Ba/F3 cells expressing EML4-ALK variant 1 with ALK... | ALK | ALK p.Gly1202Arg (p.G1202R) ALK p.Gly1202Arg (p.G1202R) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| EML4-ALK with G1269A mutation was tested for sensi... | ALK | ALK p.Gly1269Ala (p.G1269A) ALK p.Gly1269Ala (p.G1269A) | Sensitivity | true | CIViC Evidence | detail |
| A 51 year old female never smoker was diagnosed wi... | ALK | ALK p.Ile1171Thr (p.I1171T) ALK p.Ile1171Thr (p.I1171T) | Sensitivity | true | CIViC Evidence | detail |
| Patients with metastatic colorectal cancer with ST... | ALK | ALK STRN-ALK | Sensitivity | true | CIViC Evidence | detail |
| In this case report, a patient with metastatic, AL... | ALK | ALK EML4-ALK C1156Y | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT03784014 | Active, not recruiting | Phase 3 | Molecular Profiling of Advanced Soft-tissue Sarcomas | October 19, 2019 | October 2025 |
| NCT02584933 | Active, not recruiting | Phase 4 | Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study | December 11, 2015 | June 9, 2025 |
| NCT03737994 | Active, not recruiting | Phase 2 | Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer | July 25, 2019 | September 21, 2024 |
| NCT02321501 | Active, not recruiting | Phase 1 | Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer | June 22, 2016 | December 31, 2024 |
| NCT03611738 | Active, not recruiting | Phase 1 | Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC | February 1, 2019 | April 2025 |
| NCT03501368 | Active, not recruiting | Phase 1 | Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma | June 27, 2018 | August 2024 |
| NCT05100134 | Available | Managed Access Programs for LDK378, Ceritinib | |||
| NCT02422589 | Completed | Phase 1 | 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 | October 23, 2015 | December 12, 2017 |
| NCT01742286 | Completed | Phase 1 | Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) | August 28, 2013 | April 26, 2019 |
| NCT01828099 | Completed | Phase 3 | LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer | July 9, 2013 | January 7, 2024 |
| NCT01828112 | Completed | Phase 3 | LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib | June 28, 2013 | November 10, 2023 |
| NCT02227940 | Completed | Phase 1 | Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer | January 8, 2015 | February 12, 2019 |
| NCT02292550 | Completed | Phase 1 | Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer. | May 14, 2015 | September 26, 2018 |
| NCT02299505 | Completed | Phase 1 | 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) | April 9, 2015 | March 6, 2020 |
| NCT02336451 | Completed | Phase 2 | 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 | April 1, 2015 | February 6, 2019 |
| NCT03546894 | Completed | A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors | July 23, 2018 | February 13, 2023 | |
| NCT04647110 | Completed | Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers. | December 14, 2020 | March 15, 2021 | |
| NCT05834348 | Recruiting | A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. | June 26, 2023 | February 3, 2025 | |
| NCT02559778 | Recruiting | Phase 2 | Pediatric Precision Laboratory Advanced Neuroblastoma Therapy | September 2015 | September 2035 |
| NCT05489887 | Recruiting | Phase 2 | Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma | September 14, 2022 | September 2033 |
| NCT03087448 | Terminated | Phase 1 | Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) | September 9, 2017 | April 30, 2022 |
| NCT02186821 | Terminated | Phase 2 | Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE) | September 17, 2014 | December 13, 2017 |
| NCT02513667 | Terminated | Phase 2 | Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma | November 2015 | May 29, 2021 |
| NCT02780128 | Terminated | Phase 1 | Next Generation Personalized Neuroblastoma Therapy | July 2016 | August 2022 |
| NCT02587650 | Terminated | Phase 2 | Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma | March 26, 2015 | July 12, 2018 |
| NCT02638909 | Terminated | Phase 2 | Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies | December 2015 | March 29, 2018 |
| NCT02343679 | Withdrawn | Phase 2 | Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies | May 2015 | October 2022 |
| NCT02729961 | Withdrawn | Phase 1/Phase 2 | Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma | January 3, 2018 | July 1, 2023 |
| NCT02289144 | Withdrawn | Phase 2 | Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer | June 2015 | January 2019 |
- Trade name (Drug list of Screening Committee of Anticancer Drugs)
- Zykadia
- US Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2014
- Japan Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- Phase III
- Target (Drug list of Screening Committee of Anticancer Drugs)
- ALK
- Disease name (Drug list of Screening Committee of Anticancer Drugs)
- 非小細胞肺がん（ALK fusion gene）