دورية أكاديمية
Phase 1/2a Study of Rivoceranib, a Selective VEGFR-2 Angiogenesis Inhibitor, in Patients with Advanced Solid Tumors.
| العنوان: | Phase 1/2a Study of Rivoceranib, a Selective VEGFR-2 Angiogenesis Inhibitor, in Patients with Advanced Solid Tumors. |
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| المؤلفون: | Kang YK; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Ryu MH; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Hong YS; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Choi CM; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Kim TW; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Ryoo BY; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Kim JE; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Weis JR; University of Utah and Huntsman Cancer Institute, Salt Lake City, UT, USA., Kingsford R; University of Utah and Huntsman Cancer Institute, Salt Lake City, UT, USA., Park CH; Elevar Therapeutics, Fort Lee, NJ, USA., Jang S; Elevar Therapeutics, Fort Lee, NJ, USA., McGinn A; Elevar Therapeutics, Fort Lee, NJ, USA., Werner TL; University of Utah and Huntsman Cancer Institute, Salt Lake City, UT, USA., Sharma S; Translational Genomics Research Institute, Phoenix, AZ, USA. |
| المصدر: | Cancer research and treatment [Cancer Res Treat] 2024 Jul; Vol. 56 (3), pp. 743-750. Date of Electronic Publication: 2024 Jan 18. |
| نوع المنشور: | Journal Article; Clinical Trial, Phase I; Clinical Trial, Phase II; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: The Association Country of Publication: Korea (South) NLM ID: 101155137 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2005-9256 (Electronic) Linking ISSN: 15982998 NLM ISO Abbreviation: Cancer Res Treat Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Seoul, Korea : The Association, |
| مواضيع طبية MeSH: | Neoplasms*/drug therapy , Neoplasms*/pathology , Vascular Endothelial Growth Factor Receptor-2*/antagonists & inhibitors , Angiogenesis Inhibitors*/therapeutic use , Angiogenesis Inhibitors*/administration & dosage , Angiogenesis Inhibitors*/adverse effects , Angiogenesis Inhibitors*/pharmacokinetics, Humans ; Male ; Female ; Middle Aged ; Aged ; Adult ; Treatment Outcome ; Maximum Tolerated Dose ; Neoplasm Staging ; Protein Kinase Inhibitors/therapeutic use ; Protein Kinase Inhibitors/adverse effects ; Protein Kinase Inhibitors/administration & dosage ; Protein Kinase Inhibitors/pharmacokinetics |
| مستخلص: | Purpose: This study aimed to report the results from an early-phase study of rivoceranib, an oral tyrosine kinase inhibitor highly selective for vascular endothelial growth factor receptor 2, in patients with advanced solid tumors. Materials and Methods: In this open-label, single-arm, dose-escalating, multicenter three-part phase 1/2a trial, patients had advanced solid tumors refractory to conventional therapy. Part 1 evaluated the safety and pharmacokinetics of five ascending once-daily doses of rivoceranib from 81 mg to 685 mg. Part 2 evaluated the safety and antitumor activity of once-daily rivoceranib 685 mg. Part 3 was conducted later, due to lack of maximum tolerated dose determination in part 1, to evaluate the safety and preliminary efficacy of once-daily rivoceranib 805 mg in patients with unresectable or advanced gastric cancer. Results: A total of 61 patients were enrolled in parts 1 (n=25), 2 (n=30), and 3 (n=6). In parts 1 and 2, patients were white (45.5%) or Asian (54.5%), and 65.6% were male. The most common grade ≥ 3 adverse events were hypertension (32.7%), hyponatremia (10.9%), and hypophosphatemia (10.9%). The objective response rate (ORR) was 15.2%. In part 3, dose-limiting toxicities occurred in two out of six patients: grade 3 febrile neutropenia decreased appetite, and fatigue. The ORR was 33%. Conclusion: The recommended phase 2 dose of rivoceranib was determined to be 685 mg once daily, which showed adequate efficacy with a manageable safety profile (NCT01497704 and NCT02711969). |
| معلومات مُعتمدة: | Bukwang Pharm Co.; Elevar Therapeutics |
| فهرسة مساهمة: | Keywords: Apatinib; Rivoceranib; Solid tumors; Stomach neoplasms |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02711969; NCT01497704 |
| المشرفين على المادة: | EC 2.7.10.1 (Vascular Endothelial Growth Factor Receptor-2) 0 (Angiogenesis Inhibitors) EC 2.7.10.1 (KDR protein, human) 0 (Protein Kinase Inhibitors) |
| تواريخ الأحداث: | Date Created: 20240125 Date Completed: 20240717 Latest Revision: 20240717 |
| رمز التحديث: | 20240717 |
| DOI: | 10.4143/crt.2023.980 |
| PMID: | 38271925 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2005-9256 |
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| DOI: | 10.4143/crt.2023.980 |