التفاصيل البيبلوغرافية
| العنوان: |
Dose-escalation trial of the ALK, MET & ROS1 inhibitor, crizotinib, in patients with advanced cancer. |
| المؤلفون: |
Clark, Jeffrey W, Camidge, D Ross, Kwak, Eunice L, Maki, Robert G, Shapiro, Geoffrey I, Chen, Isan, Tan, Weiwei, Randolph, Sophia, Christensen, James G, Ozeck, Mark, Tang, Yiyun, Wilner, Keith D, Salgia, Ravi |
| المصدر: |
Future Oncology; Jan2020, Vol. 16 Issue 1, p4289-4301, 13p |
| مصطلحات موضوعية: |
THERAPEUTIC use of antineoplastic agents, PROTEINS, RESEARCH, DRUG dosage, CLINICAL trials, RESEARCH methodology, PROGNOSIS, ANTINEOPLASTIC agents, EVALUATION research, MEDICAL cooperation, COMPARATIVE studies, PROTEIN-tyrosine kinases, DOSE-effect relationship in pharmacology, GENES, TUMORS, LONGITUDINAL method, DRUG toxicity, CHEMICAL inhibitors |
| مستخلص: |
Aim: This first-in-human, dose-finding study evaluated safety, pharmacokinetics and pharmacodynamics of crizotinib and established a recommended Phase II dose (RP2D) among patients with advanced solid malignancies. Patients & methods: Patients received oral crizotinib in a 3 + 3 dose escalation design. Results: Thirty-six patients received crizotinib (50 mg once daily-300 mg twice daily); maximum tolerated dose (and RP2D) was 250 mg twice daily. Most patients (89%) experienced ≥1 treatment-related adverse event. Three patients had grade 3 dose-limiting toxicities: alanine aminotransferase increased (n = 1) and fatigue (n = 2). Generally, an increase in soluble MET was found with increasing crizotinib concentrations. Conclusion: Crizotinib demonstrated a favorable safety profile. The observed pharmacodynamic effect on soluble MET provide evidence for targeted MET inhibition by crizotinib. Clinicaltrials. gov identifier: NCT00585195. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
