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


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  • ||||||||||  Biomarker, Journal, PD(L)-1 Biomarker, IO Biomarker:  Tissue and Blood Biomarkers in Lung Cancer: A Review. (Pubmed Central) -  May 2, 2019   
    For predicting response to single agent pembrolizumab in the first-line treatment of patients with advanced adenocarcinoma or squamous cell NSCLCs, PD-L1 should be measured by an approved assay (e.g., PD-L1 IHC 22C3 pharmDx method)...Serum biomarkers may also be of use in determining prognosis and monitoring response to systemic therapies. With the increasing use of biomarkers, personalized treatment especially for patients with adenocarcinoma-type NSCLC is finally on the horizon.
  • ||||||||||  Clinical, Journal:  Treatment of ALK-positive nonsmall cell lung cancer: recent advances. (Pubmed Central) -  Apr 26, 2019   
    Our review will discuss the recent phase III data with ceritinib and alectinib as well as clinical trials with other ALK inhibitors. We will also address two important issues in the management of ALK-positive NSCLC, prevention and treatment of brain metastases and management of emergent ALK-TKI resistance mechanisms.
  • ||||||||||  Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis
    Journal, Heterogeneity:  Genomic heterogeneity of ALK fusion breakpoints in non-small-cell lung cancer. (Pubmed Central) -  Apr 17, 2019   
    Survival analysis of patients treated with targeted ALK inhibitors demonstrates a significant difference in mean survival between patients with next-generation sequencing confirmed EML4-ALK rearrangements, and those without (20.6 months vs 5.4 months, P<0.01). Together, these data demonstrate abundant genomic heterogeneity among ALK-rearranged lung adenocarcinoma, which may account for differences in treatment response with targeted ALK inhibitors.Modern Pathology advance online publication, 12 January 2018; doi:10.1038/modpathol.2017.181.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Enrollment change, Metastases:  Ceritinib Rare Indications Study in ALK+ Tumors (clinicaltrials.gov) -  Apr 16, 2019   
    P2,  N=22, Completed, 
    Together, these data demonstrate abundant genomic heterogeneity among ALK-rearranged lung adenocarcinoma, which may account for differences in treatment response with targeted ALK inhibitors.Modern Pathology advance online publication, 12 January 2018; doi:10.1038/modpathol.2017.181. N=106 --> 22
  • ||||||||||  Clinical, Review, Journal:  Lung Toxicity in Non-Small-Cell Lung Cancer Patients Exposed to ALK Inhibitors: Report of a Peculiar Case and Systematic Review of the Literature. (Pubmed Central) -  Apr 10, 2019   
    ...Crizotinib was responsible for pulmonary adverse events (AEs) in 1.8% of exposed patients (49 of 2706)...Pulmonary AEs during therapy with ceritinib, alectinib, and lorlatinib occurred in 1.1%, 2.6%, and 1.8% of the patients, respectively...Lung toxicity is a rare albeit potentially severe side effect in NSCLC patients receiving ALK-TKIs, apparently more frequent with brigatinib. Its early recognition and treatment are crucial for the best outcome of this subgroup of patients, whose overall prognosis is being improved by the availability of several targeted agents.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Enrollment change, Metastases:  Ceritinib Rare Indications Study in ALK+ Tumors (clinicaltrials.gov) -  Mar 5, 2019   
    P2,  N=106, Completed, 
    Its early recognition and treatment are crucial for the best outcome of this subgroup of patients, whose overall prognosis is being improved by the availability of several targeted agents. N=22 --> 106
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Trial primary completion date, Metastases:  Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer (clinicaltrials.gov) -  Jan 17, 2019   
    P2,  N=100, Recruiting, 
    Active, not recruiting --> Recruiting Trial primary completion date: Dec 2019 --> Dec 2020
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Enrollment open, Trial initiation date, Trial primary completion date:  A Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement (clinicaltrials.gov) -  Jan 11, 2019   
    P2,  N=46, Recruiting, 
    Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019 Not yet recruiting --> Recruiting | Initiation date: Jan 2018 --> Jul 2018 | Trial primary completion date: Dec 2019 --> May 2020
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Trial completion, Enrollment change, Metastases:  Ceritinib Rare Indications Study in ALK+ Tumors (clinicaltrials.gov) -  Dec 4, 2018   
    P2,  N=22, Completed, 
    Recruiting --> Active, not recruiting Recruiting --> Completed | N=106 --> 22
  • ||||||||||  Alunbrig (brigatinib) / Takeda
    Journal:  The brigatinib experience: a new generation of therapy for ALK-positive non-small-cell lung cancer. (Pubmed Central) -  Nov 29, 2018   
    Brigatinib, a next-generation ALK inhibitor, shows promising activity in ALK-rearranged NSCLC that have previously received crizotinib with response rates in ALTA ranging from 42-50%, intracranial response 42-67% and median progression-free survival 9.2-12.9 months. Randomized Phase III trial, ALTA-1 L is investigating brigatinib in ALK inhibitor-naive patients.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Enrollment open, Metastases:  Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC (clinicaltrials.gov) -  Nov 2, 2018   
    P1,  N=48, Recruiting, 
    Initiation date: Aug 2018 --> Feb 2019 Not yet recruiting --> Recruiting
  • ||||||||||  Review, Journal:  Directed Therapies in Anaplastic Lymphoma Kinase-rearranged Non-small Cell Lung Cancer. (Pubmed Central) -  Sep 16, 2018   
    Of considerable importance when considering such therapies is the ability of each to overcome mutations conferring acquired resistance, as well as penetrate the central nervous system (CNS), the most common site of metastasis and traditionally the most difficult to breach. Herein is a review of the efficacy, indications, and degree of CNS penetration for the ALK-targeting agents crizotinib, ceretinib, alectinib, brigatinib, and lorlatinib, as well as a summary of ongoing clinical trials comparing these drugs.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Trial primary completion date:  ASCEND-3: LDK378 in Crizotinib na (clinicaltrials.gov) -  Aug 14, 2018   
    P2,  N=125, Completed, 
    Initiation date: Jun 2018 --> Oct 2018 Trial primary completion date: Jun 2014 --> Jan 2018
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Trial completion, Trial completion date:  LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib. (clinicaltrials.gov) -  Jul 31, 2018   
    P2,  N=20, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> May 2018
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Enrollment closed, Trial completion date, Trial primary completion date:  Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) (clinicaltrials.gov) -  Jul 23, 2018   
    P1,  N=83, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> May 2018 Recruiting --> Active, not recruiting | Trial completion date: May 2018 --> Mar 2019 | Trial primary completion date: May 2018 --> Mar 2019
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Trial completion:  ASCEND-3: LDK378 in Crizotinib na (clinicaltrials.gov) -  Jul 20, 2018   
    P2,  N=126, Completed, 
    Recruiting --> Active, not recruiting | Trial completion date: May 2018 --> Mar 2019 | Trial primary completion date: May 2018 --> Mar 2019 Active, not recruiting --> Completed
  • ||||||||||  Zykadia (ceritinib) / Novartis, Kisqali (ribociclib) / Novartis
    Trial primary completion date:  NEPENTHE: Next Generation Personalized Neuroblastoma Therapy (clinicaltrials.gov) -  Jul 19, 2018   
    P1,  N=105, Recruiting, 
    Active, not recruiting --> Completed Trial primary completion date: May 2018 --> Jul 2020
  • ||||||||||  Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
    Enrollment open:  Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma (clinicaltrials.gov) -  Jun 21, 2018   
    P2,  N=27, Recruiting, 
    Trial completion date: Aug 2018 --> Feb 2019 | Trial primary completion date: Aug 2018 --> Feb 2019 Not yet recruiting --> Recruiting