Alecensa (alectinib) / Roche 
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 13 Diseases   52 Trials   52 Trials   3235 News 


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  • ||||||||||  Enrollment change, Trial withdrawal:  SMMART Adaptive Clinical Treatment (ACT) Trial (clinicaltrials.gov) -  Jan 23, 2024   
    P1,  N=0, Withdrawn, 
    Liquid biopsy may reveal the rare fusion forms of ALK, precisely guiding personalized treatment, and providing a reference method for longitudinal monitoring and efficacy evaluation of ALK-tyrosine kinase inhibitors in NSCLC patients. N=25 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Lorbrena (lorlatinib) / Pfizer
    Review, Journal:  From Development to Place in Therapy of Lorlatinib for the Treatment of ALK and ROS1 Rearranged Non-Small Cell Lung Cancer (NSCLC). (Pubmed Central) -  Jan 11, 2024   
    So, when prescribing lorlatinib, clinicians must face two diametrically opposed characteristics: a great therapeutic potential without the intrinsic limitations of its precursor TKIs, a cytotoxic activity threatened by suboptimal tolerability, and the unavoidable onset of resistance mechanisms we cannot properly manage yet. In this paper, we give a critical point of view on the stepwise introduction of this promising drug into clinical practice, starting from its innovative molecular and biochemical properties to intriguing future developments, without forgetting its weaknesses.
  • ||||||||||  Alecensa (alectinib) / Roche
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date:  The Food-effect on Alectinib Pharmacokinetics (clinicaltrials.gov) -  Jan 11, 2024   
    P=N/A,  N=10, Enrolling by invitation, 
    In this paper, we give a critical point of view on the stepwise introduction of this promising drug into clinical practice, starting from its innovative molecular and biochemical properties to intriguing future developments, without forgetting its weaknesses. Not yet recruiting --> Enrolling by invitation | Trial completion date: Mar 2024 --> Mar 2025 | Initiation date: Mar 2023 --> Feb 2024 | Trial primary completion date: Mar 2024 --> Mar 2025
  • ||||||||||  Alecensa (alectinib) / Roche
    Trial primary completion date, Metastases:  Alectinib Pharmacokinetic in Patients With NSCLC (clinicaltrials.gov) -  Jan 11, 2024   
    P1/2,  N=45, Recruiting, 
    Not yet recruiting --> Enrolling by invitation | Trial completion date: Mar 2024 --> Mar 2025 | Initiation date: Mar 2023 --> Feb 2024 | Trial primary completion date: Mar 2024 --> Mar 2025 Trial primary completion date: Dec 2023 --> Dec 2024
  • ||||||||||  Alecensa (alectinib) / Roche
    Enrollment open, Trial completion date, Trial primary completion date:  DURABLE: Delayed or Upfront Brain RAdiotherapy in Treatment na (clinicaltrials.gov) -  Jan 8, 2024   
    P1/2,  N=56, Recruiting, 
    The evidence presented in our study may help select patients with ALK-positive tumors suitable for treatment escalation and closer brain follow-up. Not yet recruiting --> Recruiting | Trial completion date: Feb 2025 --> Jan 2027 | Trial primary completion date: Feb 2024 --> Jan 2026
  • ||||||||||  Avastin (bevacizumab) / Roche, IBI-323 / Innovent Biologics, Alecensa (alectinib) / Roche
    Biomarker, Enrollment open, Trial completion date, Trial primary completion date:  Efficacy and Biomarker Explanation of IBI-323 + Bevacizumab Plus Platinum Based Chemotherapy on ALK-Rearranged NSCLC (clinicaltrials.gov) -  Dec 27, 2023   
    P2,  N=70, Recruiting, 
    The case diversifies the array of ALK fusion partners and holds clinical relevance in refining therapeutic choices for KIF13A-ALK fusion-associated lung cancer. Not yet recruiting --> Recruiting | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Avastin (bevacizumab) / Roche, Alecensa (alectinib) / Roche
    Trial completion date, Trial primary completion date, Metastases:  Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK (clinicaltrials.gov) -  Dec 26, 2023   
    P2,  N=30, Not yet recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Dec 2024 --> Dec 2025 Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Nov 2023 --> Nov 2024
  • ||||||||||  Alecensa (alectinib) / Roche
    Biomarker, Trial completion date, Trial initiation date, Trial primary completion date:  Drugs-SNPs: Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms (clinicaltrials.gov) -  Dec 15, 2023   
    P2/3,  N=600, Not yet recruiting, 
    The design of the microtracer food-effect study allowed estimation of the food-effect with minimal influence on therapeutic treatment and reducing patient burden compared to the traditional study design for toxic drugs with long half-lives. Trial completion date: May 2024 --> Dec 2024 | Initiation date: Nov 2023 --> Mar 2024 | Trial primary completion date: May 2024 --> Nov 2024
  • ||||||||||  Alecensa (alectinib) / Roche
    Journal:  Density Functional Theory and Raman Spectroscopy Studies of Adsorption Sites of Au Nanoparticles with Alectinib. (Pubmed Central) -  Dec 14, 2023   
    Comparing the results of the DFT theory and SERS experiment, alectinib and AuNPs can form Au-N6 bonds primarily through chemical adsorption of N6 atoms, and the experimental results showed that the enhancement factor (EFCHEM) could reach 4.27. The results provide a theoretical basis for exploring the mechanism of chemical enhancement between AuNPs and alectinib.
  • ||||||||||  Alecensa (alectinib) / Roche
    Biomarker, Clinical, Observational data, Retrospective data, Review, Clinical Trial,Phase II, Journal:  Metastasis-directed radiotherapy for non-small cell lung cancer failured under TKI: A case report and literature review. (Pubmed Central) -  Dec 4, 2023   
    After RT, alectinib was initiated and the patient had a good clinico-radiological response in both intracranial and extracranial regions...She has been alive with the initial systemic therapy agent for more than 4years without evidence of neither disease nor toxicity. SRS/SBRT may eradicate the TKI-resistant tumoral clones and it may prevent switching the systemic therapy, even if there is a failure.
  • ||||||||||  Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Heterogeneity:  DARWIN II: Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity (clinicaltrials.gov) -  Dec 4, 2023   
    P2,  N=50, Active, not recruiting, 
    SRS/SBRT may eradicate the TKI-resistant tumoral clones and it may prevent switching the systemic therapy, even if there is a failure. Recruiting --> Active, not recruiting | N=119 --> 50 | Trial completion date: Nov 2025 --> May 2026 | Trial primary completion date: Nov 2024 --> May 2026
  • ||||||||||  Xospata (gilteritinib) / Astellas, Alecensa (alectinib) / Roche
    Journal:  Efficacy of gilteritinib in comparison with alectinib for the treatment of ALK-rearranged non-small cell lung cancer. (Pubmed Central) -  Nov 13, 2023   
    This suggests that IL-15 production along with NK cell infiltration may constitute components of the gilteritinib-mediated antitumor responses in ALK-rearranged NSCLCs. In conclusion, gilteritinib demonstrated significantly improved antitumor efficacy compared with alectinib against ALK-rearranged NSCLC cells, which can warrant its candidacy for use in anticancer regimens, after further examination in clinical trial settings.
  • ||||||||||  Review, Journal:  Update of Diagnosis and Targeted Therapy for ALK Inflammation Myofibroblastic Tumor. (Pubmed Central) -  Nov 8, 2023   
    After the approval of crizotinib, other ALK-TKIs, such as ceritinib, alectinib, brigatinib, and lorlatinib, have proven their efficacy on ALK IMT with sporadic case reports. The sequential treatments of targeted therapies in may provide the insight into the choice of ALK-TKIs in different lines of treatment for unresectable ALK IMT.
  • ||||||||||  Journal:  Are novel oral oncolytics underdosed in obese patients? (Pubmed Central) -  Oct 31, 2023   
    Higher body weight was only correlated with lower plasma trough levels for crizotinib, imatinib, and trametinib. Therefore, patients with a high body weight may require dose escalation to obtain adequate target levels when treated with these oral oncolytics.
  • ||||||||||  Alecensa (alectinib) / Roche
    Journal:  A Combination of Alectinib and DNA-Demethylating Agents Synergistically Inhibits Anaplastic-Lymphoma-Kinase-Positive Anaplastic Large-Cell Lymphoma Cell Proliferation. (Pubmed Central) -  Oct 28, 2023   
    Crizotinib and alectinib are first- and second-generation ALK TKIs, respectively, approved for the treatment of ALK-positive ALCL (ALK ALCL) and ALK NSCLC...Thus, to improve the clinical outcomes of ALK ALCL therapy, we investigated the synergistic efficacy of the combination of alectinib and the DNA-demethylating agent azacytidine, decitabine, or OR-2100 (an orally bioavailable decitabine derivative)...The combination of alectinib and OR-2100 markedly altered gene expression in ALCL cells, including that of genes implicated in apoptotic signaling, which possibly contributed to the synergistic anti-ALCL effects of this drug combination. Therefore, alectinib and OR-2100 combination therapy has the potential to improve the outcomes of patients with ALK ALCL.
  • ||||||||||  Tagrisso (osimertinib) / AstraZeneca
    Journal, PD(L)-1 Biomarker:  Acquired EML4-ALK fusion and EGFR C797S in cis mutation as resistance mechanisms to osimertinib in a non-small cell lung cancer patient with EGFR L858R/T790M. (Pubmed Central) -  Oct 23, 2023   
    We present a case of a stage IV lung adenocarcinoma patient harboring EGFR L858R, acquired T790M after treatment with first-line gefitinib...A combination targeted therapy of osimertinib plus alectinib was initiated, with a progression-free survival of 5?months without any serious adverse reaction...Then therapy was changed to pemetrexed combined with bevacizumab plus camrelizumab, but no obvious effect was observed...Our case shows that EML4-ALK fusion is a rare but critical resistance mechanism to osimertinib, and C797S mutation in cis may be an underlying mechanism of acquired resistance mutation in double TKIs therapy. Furthermore, molecular detection and rebiopsy play important roles in the selection of therapeutic strategies when the disease progresses.
  • ||||||||||  Promacta (eltrombopag) / Novartis, Alecensa (alectinib) / Roche
    Journal:  Unlocking potential inhibitors for Bruton's tyrosine kinase through in-silico drug repurposing strategies. (Pubmed Central) -  Oct 22, 2023   
    All-atom MD simulations provided insights into the binding interactions and stability of the identified compounds, which will be helpful for further experimental validation and optimization. Overall, our study demonstrates that drug repurposing is a promising approach to identify potential inhibitors of BTK and highlights the importance of computational methods in drug discovery.
  • ||||||||||  Xalkori (crizotinib) / Pfizer
    Journal, Monotherapy, Metastases:  TCM monotherapy achieves significant efficacy in crizotinib-refractory advanced NSCLC with brain metastasis. (Pubmed Central) -  Oct 22, 2023   
    Overall, our study demonstrates that drug repurposing is a promising approach to identify potential inhibitors of BTK and highlights the importance of computational methods in drug discovery. This case is the first 1 in the world where TCM was introduced as monotherapy for severe conditions with extensive brain metastases and achieved remarkable efficacy.