- |||||||||| lenvatinib / Generic mfg.
Clinical, Journal: Lenvatinib-Associated Cervical Artery Dissections in a Patient with Radioiodine-Refractory Metastatic Papillary Thyroid Carcinoma. (Pubmed Central) - Mar 14, 2018 Here, we describe a case of a 34-year-old female with recurrent, metastatic, RAIR papillary thyroid cancer who, following her second week of lenvatinib treatment, developed significant CAD which resolved following the termination of the TKI therapy. Given the lack of risk factors for the disorder in the patient's history, the known cardiovascular events associated with the drug, previously described cases of arterial dissections linked to VEGF inhibitors, and the temporal relationship between the onset of symptoms and the treatment start date, a causal relationship between the CAD and lenvatinib is suggested.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date: KEYNOTE 523: Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Participants With Selected Solid Tumors (clinicaltrials.gov) - Feb 22, 2018 P1b, N=6, Active, not recruiting, Given the lack of risk factors for the disorder in the patient's history, the known cardiovascular events associated with the drug, previously described cases of arterial dissections linked to VEGF inhibitors, and the temporal relationship between the onset of symptoms and the treatment start date, a causal relationship between the CAD and lenvatinib is suggested. Trial primary completion date: Apr 2017 --> Jun 2018 | Trial completion date: May 2018 --> Jun 2018
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion, Trial primary completion date, Metastases: TALENT: Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors (clinicaltrials.gov) - Jan 17, 2018 P2, N=111, Completed, Trial primary completion date: Dec 2017 --> Mar 2018 Recruiting --> Completed | Trial primary completion date: Jul 2017 --> Dec 2017
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial initiation date, Metastases: Lenvatinib and Everolimus in Renal Cell Carcinoma (RCC) (clinicaltrials.gov) - Jan 10, 2018 P2, N=13, Not yet recruiting, Active, not recruiting --> Terminated | Trial primary completion date: Jan 2017 --> Sep 2017 Initiation date: Dec 2017 --> Mar 2018
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD), Cabometyx (cabozantinib tablet) / Exelixis
Enrollment closed, Trial primary completion date, Metastases: Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer (clinicaltrials.gov) - Dec 15, 2017 P=N/A, N=23, Active, not recruiting, QOL can be maintained on lenvatinib therapy. Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2018 --> Nov 2019
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial initiation date, PD(L)-1 Biomarker: Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC) (clinicaltrials.gov) - Nov 7, 2017 P2, N=60, Not yet recruiting, Recruiting --> Active, not recruiting Initiation date: Apr 2017 --> Dec 2017
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion, Trial primary completion date, Metastases: A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments (clinicaltrials.gov) - Sep 26, 2017 P2, N=135, Completed, Initiation date: Apr 2017 --> Dec 2017 Active, not recruiting --> Completed | Trial primary completion date: Oct 2013 --> Jan 2014
- |||||||||| Biomarker, Review, Journal: Current Management Strategy for Metastatic Renal Cell Carcinoma and Future Directions. (Pubmed Central) - Sep 8, 2017
Most recently, several new drugs including nivolumab, cabozantinib, and a combination of lenvatinib and everolimus have demonstrated acceptable toxicity and significantly improved overall survival, but evidence-based guidelines for sequencing of the approved treatment options and treatment selection based on biomarkers are still missing...Several ongoing clinical trials are evaluating sequencing, timing of cytoreductive nephrectomy, combinations of immunotherapies and targeted therapies as well as selection of the best systemic treatment. Personalized treatment based on tumor profiling is one of the brightest spots on the horizon.
- |||||||||| Retrospective data, Journal: Targeting RET in Patients With RET-Rearranged Lung Cancers: Results From the Global, Multicenter RET Registry. (Pubmed Central) - Aug 16, 2017
Of those patients, 53 received one or more RET tyrosine kinase inhibitors in sequence: cabozantinib (21 patients), vandetanib (11 patients), sunitinib (10 patients), sorafenib (two patients), alectinib (two patients), lenvatinib (two patients), nintedanib (two patients), ponatinib (two patients), and regorafenib (one patient)...Conclusion Available multikinase inhibitors had limited activity in patients with RET-rearranged NSCLC in this retrospective study. Further investigation of the biology of RET-rearranged lung cancers and identification of new targeted therapeutics will be required to improve outcomes for these patients.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment change, Trial withdrawal, Metastases: Lenvatinib and Capecitabine in Patients With Advanced Malignancies (clinicaltrials.gov) - Jun 26, 2017 P1, N=0, Withdrawn, Further investigation of the biology of RET-rearranged lung cancers and identification of new targeted therapeutics will be required to improve outcomes for these patients. N=46 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Journal: Preclinical Modeling of KIF5B-RET Fusion Lung Adenocarcinoma. (Pubmed Central) - Jun 18, 2017
Interestingly, the vandetanib-resistant KIF5B-RET(G810A) mutant displayed gain-of-sensitivity (GOS) to ponatinib and lenvatinib...These results indicate that KIF5B-RET-associated lung tumors are addicted to the fusion oncogene and ponatinib is the most effective inhibitor for targeting KIF5B-RET in lung adenocarcinoma. Moreover, this study finds a novel vandetanib-resistant RET(G810A) mutation and identifies lenvatinib and ponatinib as the secondary drugs to overcome this vandetanib resistance mechanism.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment closed, Metastases: Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma (clinicaltrials.gov) - Jun 8, 2017 P2, N=33, Active, not recruiting, Moreover, this study finds a novel vandetanib-resistant RET(G810A) mutation and identifies lenvatinib and ponatinib as the secondary drugs to overcome this vandetanib resistance mechanism. Recruiting --> Active, not recruiting
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment open, Enrollment change, Trial primary completion date: A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile (clinicaltrials.gov) - May 18, 2017 P2, N=161, Recruiting, Recruiting --> Active, not recruiting | N=10 --> 6 | Trial primary completion date: May 2018 --> Apr 2017 Active, not recruiting --> Recruiting | N=41 --> 161 | Trial primary completion date: May 2019 --> Oct 2020
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