- |||||||||| Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
Enrollment open: Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma (clinicaltrials.gov) - Nov 3, 2020 P1, N=27, Recruiting, Challenges in NSCLC treatment include resistance to 3rd generation TKIs, the high cost of ALK inhibitors, and the need for further research on new drugs. Suspended --> Recruiting
- |||||||||| Zykadia (ceritinib) / Novartis
Trial completion date: Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis (clinicaltrials.gov) - Oct 19, 2020 P1, N=10, Active, not recruiting, Though the sample size is small, this is the first report of the successful in vitro & in vivo culture of CSF-CTCs from pts with LMD. Trial completion date: Sep 2020 --> Mar 2021
- |||||||||| Zykadia (ceritinib) / Novartis
[VIRTUAL] Budget IMPACT Analysis of Ceritinib for Treatment of ALK Positive Locally Advanced or Metastatic NON-SMALL Cell LUNG Cancer in China () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_808; In the total cost budget impact scenario, given China’s annual reimbursement expenditure was over 2,000 billion CNY in 2019, including ceritinib in the NRDL would potentially increase 1.2 million (0.00006%), 21.4 million (0.00107%), 46.9 million CNY (0.00235%) from 2021 to 2023 respectively, totaling 69.6 million in three years. DSA results indicated that the results were relatively insensitive to most parameters except for LC incidence.CONCLUSIONS : The analysis showed that inclusion of ceritinib in China’s national reimbursement list would result in a modest budget impact over a time horizon of 3 years.
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Zykadia (ceritinib) / Novartis, NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date, Metastases: PEDS-PLAN: Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (clinicaltrials.gov) - Sep 24, 2020 P2, N=500, Recruiting, DSA results indicated that the results were relatively insensitive to most parameters except for LC incidence.CONCLUSIONS : The analysis showed that inclusion of ceritinib in China’s national reimbursement list would result in a modest budget impact over a time horizon of 3 years. Trial completion date: Sep 2026 --> Sep 2032 | Trial primary completion date: Sep 2025 --> Sep 2027
- |||||||||| 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.
- |||||||||| Clinical, Review, Journal: Optimal Care for Patients with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer: A Review on the Role and Utility of ALK Inhibitors. (Pubmed Central) - Aug 22, 2020
The ultimate acquisition of resistance to ALK-inhibitor therapy poses a challenge to ongoing research efforts, in addition to the routine management of these patients in the clinic. This review provides a summary of the clinical development of crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib and highlights current management paradigms, current and evolving clinical information, emerging clinical decision-making and sequencing of therapy in advanced, metastatic, or recurrent ALK-positive NSCLC.
- |||||||||| 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 completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Aug 2021 --> Aug 2022 Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jun 2020 --> Jun 2021
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