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A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer

Background: Cancer is a major health problem worldwide and the leading cause of death in many countries. Preclinical studies have shown the therapeutic anticancer effects of SH003, a novel herbal medicine containing Astragalus membranaceus, Angelica gigas, and Trichosanthes kirilowii. The present st...

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Autores principales: Cheon, Chunhoo, Ko, Seong-Gyu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7081467/
https://www.ncbi.nlm.nih.gov/pubmed/32186413
http://dx.doi.org/10.1177/1534735420911442
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author Cheon, Chunhoo
Ko, Seong-Gyu
author_facet Cheon, Chunhoo
Ko, Seong-Gyu
author_sort Cheon, Chunhoo
collection PubMed
description Background: Cancer is a major health problem worldwide and the leading cause of death in many countries. Preclinical studies have shown the therapeutic anticancer effects of SH003, a novel herbal medicine containing Astragalus membranaceus, Angelica gigas, and Trichosanthes kirilowii. The present study investigated the maximum tolerated dose of SH003 in patients with solid cancers. Methods: This open-label, dose-escalation trial used the traditional 3 + 3 dose-escalation design. Patients with solid cancers were recruited and administered 1 to 4 tablets of SH003 thrice daily for 3 weeks according to the dose level. Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE). Dose-limiting toxicities (DLTs) were defined as Grade 3 or higher adverse events based on CTCAE. The maximum tolerated dose was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. Results: The present study enrolled 11 patients. A total of 31 adverse events occurred. According to the CTCAE, all the observed adverse events were grade 2 or less and no adverse events of grade 3 or more corresponding to DLT occurred. Conclusion: The study results indicated that the maximum tolerated dose of SH003 was 4800 mg/day. A Phase 2 study is required to determine the efficacy of SH003 in patients with cancer at a dose of 4800 mg/day or less.
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spelling pubmed-70814672020-03-25 A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer Cheon, Chunhoo Ko, Seong-Gyu Integr Cancer Ther Research Article Background: Cancer is a major health problem worldwide and the leading cause of death in many countries. Preclinical studies have shown the therapeutic anticancer effects of SH003, a novel herbal medicine containing Astragalus membranaceus, Angelica gigas, and Trichosanthes kirilowii. The present study investigated the maximum tolerated dose of SH003 in patients with solid cancers. Methods: This open-label, dose-escalation trial used the traditional 3 + 3 dose-escalation design. Patients with solid cancers were recruited and administered 1 to 4 tablets of SH003 thrice daily for 3 weeks according to the dose level. Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE). Dose-limiting toxicities (DLTs) were defined as Grade 3 or higher adverse events based on CTCAE. The maximum tolerated dose was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. Results: The present study enrolled 11 patients. A total of 31 adverse events occurred. According to the CTCAE, all the observed adverse events were grade 2 or less and no adverse events of grade 3 or more corresponding to DLT occurred. Conclusion: The study results indicated that the maximum tolerated dose of SH003 was 4800 mg/day. A Phase 2 study is required to determine the efficacy of SH003 in patients with cancer at a dose of 4800 mg/day or less. SAGE Publications 2020-03-18 /pmc/articles/PMC7081467/ /pubmed/32186413 http://dx.doi.org/10.1177/1534735420911442 Text en © The Author(s) 2020 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Research Article
Cheon, Chunhoo
Ko, Seong-Gyu
A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer
title A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer
title_full A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer
title_fullStr A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer
title_full_unstemmed A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer
title_short A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer
title_sort phase i study to evaluate the safety of the herbal medicine sh003 in patients with solid cancer
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7081467/
https://www.ncbi.nlm.nih.gov/pubmed/32186413
http://dx.doi.org/10.1177/1534735420911442
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