Zykadia (ceritinib) / Novartis 
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 20 Diseases   19 Trials   19 Trials   1670 News 


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  • ||||||||||  Review, Journal:  Diagnosis and Treatment of ALK Aberrations in Metastatic NSCLC. (Pubmed Central) -  Aug 23, 2020   
    Several more expensive and time-consuming methods are also available nowadays which have the advantage to detect even rarer uncommon ALK fusion variants and mutations in tumour or blood samples. A review of the evolving testing-treatment landscape is needed to highlight the importance of properly diagnosing and treating this group of patients.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Clinical, Journal:  Partial Response to Ceritinib in a Patient With Abdominal Inflammatory Myofibroblastic Tumor Carrying a TFG-ROS1 Fusion. (Pubmed Central) -  Aug 19, 2020   
    This report provides the first published demonstration of a patient with IMT with ROS1 fusion successfully treated using ceritinib. Our study suggests that targeting ROS1 fusions using the small molecule inhibitor shows promise as an effective therapy in patients with IMT carrying this genetic alteration, but this requires further investigation in large clinical trials.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Retrospective data, Journal:  Ceritinib-Induced Organizing Pneumonia in Lung Cancer: A Retrospective Analysis. (Pubmed Central) -  Jul 17, 2020   
    OP occurs frequently during ceritinib treatment and must be distinguished from disease progression. OP could be reversible without fatal complications and its occurrence is associated with better survival outcomes.
  • ||||||||||  Clinical, PK/PD data, Review, Journal:  Clinical Pharmacokinetics of Anaplastic Lymphoma Kinase Inhibitors in Non-Small-Cell Lung Cancer. (Pubmed Central) -  Jul 9, 2020   
    Although the absorption, distribution, and excretion of anaplastic lymphoma kinase inhibitors are regulated by drug transporters, their transporter-mediated pharmacokinetics have not yet been elucidated in detail in patients with non-small-cell lung cancer. Further research to analyze the contribution of drug transporters to the pharmacokinetics of anaplastic lymphoma kinase inhibitors in patients with non-small-cell lung cancer will be helpful for understanding the mechanisms of the inter-individual differences in the pharmacokinetics of anaplastic lymphoma kinase inhibitors.
  • ||||||||||  Trial completion date, Trial primary completion date, Metastases:  MatchMel: Molecular Profiling and Matched Targeted Therapy for Patients With Metastatic Melanoma (clinicaltrials.gov) -  Jul 7, 2020   
    P2,  N=1000, Not yet recruiting, 
    Further research to analyze the contribution of drug transporters to the pharmacokinetics of anaplastic lymphoma kinase inhibitors in patients with non-small-cell lung cancer will be helpful for understanding the mechanisms of the inter-individual differences in the pharmacokinetics of anaplastic lymphoma kinase inhibitors. Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Aug 2021 --> Aug 2022
  • ||||||||||  Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
    Trial completion date, Trial primary completion date, Metastases:  Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) -  Jul 7, 2020   
    P1/2,  N=69, Recruiting, 
    Trial primary completion date: Jun 2020 --> Sep 2020 Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jun 2020 --> Jun 2021
  • ||||||||||  Review, Journal:  Therapeutic strategies in advanced ALK positive non-small cell lung cancer (Pubmed Central) -  Jun 28, 2020   
    The emergence of crizotinib drug resistance has prompted the development of next generation drugs including ceritinb, alectinib, brigatinib and lorlatinib. The ability to quickly develop targeted therapies against specific oncogenic drivers will require close co-operation between pathologists, pulmonologists and oncologists in the future to keep pace with drug discoveries and to define optimal therapeutic strategies.
  • ||||||||||  Journal:  Drug discovery targeting anaplastic lymphoma kinase (ALK). (Pubmed Central) -  Jun 26, 2020   
    This review provides an overview of the physiological and biological functions of ALK, the discovery and development of ALK drugs by focusing on their chemotypes, inhibitory activity, selectivity and resistance, as well as current status. Additionally, the mechanism of drug resistance and potential therapeutic strategies to overcome drug resistance are also summarized.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Preclinical, Journal, PD(L)-1 Biomarker, IO Biomarker:  In vitro and in vivo synergistic efficacy of ceritinib combined with PD-L1 inhibitor in ALK-rearranged NSCLC. (Pubmed Central) -  Jun 25, 2020   
    CER could synergize with PD-1/PD-L1 blockade to yield enhanced anti-tumor responses along with favorable tolerability of adverse effects. CER and PD-L1 inhibitor combined produced a synergistic antineoplastic efficacy in vitro and in vivo, which provide a key insight and proof of principle for evaluating CER plus PD-L1 blockade as combination therapy in clinical therapeutic practice.
  • ||||||||||  Trial initiation date, Adverse events, Checkpoint inhibition:  PD-1 Immune Checkpoint Inhibitors and Immune-Related Adverse Events: a Cohort Study (clinicaltrials.gov) -  May 27, 2020   
    P=N/A,  N=4724, Not yet recruiting, 
    Our results indicate that compared with crizotinib and alectinib, ceritinib is a cost-effective option for treatment-naïve patients with ALK-positive advanced NSCLC. Initiation date: Apr 2020 --> Jul 2020
  • ||||||||||  Zykadia (ceritinib) / Novartis, Vitrakvi (larotrectinib) / Bayer, Eli Lilly, Faslodex (fulvestrant) / AstraZeneca
    Kinase fusions drive endocrine resistance in estrogen receptor-positive breast cancer (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_3907;    
    Similarly, expression of the EML4-ALK fusion also activated growth factor signaling pathways and caused resistance to estrogen depletion and induced sensitivity to the ALK inhibitor, Ceritinib...Two patients with acquired LMNA-NTRK1 fusions and metastatic disease received larotrectinib and demonstrated clinical benefit. Overall, our findings demonstrate that kinase fusions promote endocrine resistance in ER-positive breast cancer, and suggest that fusion screening in advanced breast cancer, particularly those with ER-positive breast cancer at progression on hormone therapy can identify rare tumors harboring targetable kinase fusions.
  • ||||||||||  TPX-0131 / Turning Point Therapeutics
    TPX-0131: A next generation macrocyclic ALK inhibitor that overcomes ALK resistant mutations refractory to current approved ALK inhibitors (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_3327;    
    Second generation ALK inhibitors alectinib, ceritinib, and brigatinib were able to overcome the majority of ALK resistant mutations (L1196M, G1269A and F1174L) acquired with crizotinib...Lorlatinib, a third generation ALK inhibitor, can overcome G1202R resistance with moderate IC50 values of 40 - 60 nM in cell-based assays...Taken together, TPX-0131 is a next generation ALK inhibitor that can overcome a broad spectrum of acquired resistance mutations, especially the G1202R solvent front mutation and compound mutations (e.g. L1196M/G1202R). The nonclinical pharmacology profile of TPX-0131 warrants further preclinical investigation.
  • ||||||||||  Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis
    Frontline therapy with anti-PD1 enhances the durability of combination targeted therapy in NRAS-mutant melanoma (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_247;    
    Successive treatment with combination targeted therapy not only increases antigen presentation to T cells but also decreases recruitment of immunosuppressive MDSCs thus preventing immune escape and tumor progression. In summary, we have developed novel targeted therapy combinations that can be sequentially used with immunotherapy to maximize the durations of response in treatment of NRAS-mutant melanoma.
  • ||||||||||  Afinitor (everolimus) / Novartis
    Organoid based functional test to predict personalized treatment in cholangiocarcinoma (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_2192;    
    While these results correlate well with genomically predicted drug sensitivities, all patients showed additional drug sensitivities beyond those predicted by genomics offering patients additional potential treatment options. This study highlights the importance of functional data in a genetically heterogenous tumor type such as CCA.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Enrollment closed, Enrollment change, Trial completion date:  Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis (clinicaltrials.gov) -  May 14, 2020   
    P1,  N=10, Active, not recruiting, 
    Sequential use of ALK kinase inhibitors can be an efficient strategy to counter drug resistance. Recruiting --> Active, not recruiting | N=48 --> 10 | Trial completion date: Sep 2017 --> Sep 2020
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Journal, Pleural Effusion:  Diffuse infiltrative lung disease, pericarditis, pleural effusion and ceritinib hypersensitivity (Pubmed Central) -  May 1, 2020   
    Pleural effusion, pericarditis and diffuse pulmonary infiltration associated to ceritinib have not often been described previously. Despite few data of pulmonary toxicity related to ceritinib, the current observation highlights the need for caution and regular monitoring when using these inhibitors.
  • ||||||||||  Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis
    Journal:  ALK Inhibitors-Induced M Phase Delay Contributes to the Suppression of Cell Proliferation. (Pubmed Central) -  Apr 30, 2020   
    H2228 human lung carcinoma cells that express EML4-ALK fusion showed M phase delay in the presence of TAE684 at about IC concentrations. These results suggest that ALK plays a role in M phase regulation and ALK inhibition may contribute to the suppression of cell proliferation in ALK-expressing cancer cells.