A Phase I Trial to Evaluate the Multiple-Dose Safety and Antitumor Activity of Ursolic Acid Liposomes in Subjects with Advanced Solid Tumors
Joint Authors
Qian, Zhengzi
Song, Zheng
Zhang, Huilai
Wang, Xianhuo
Zhao, Jing
Wang, Huaqing
Zhou, Shiyong
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-03-19
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
Ursolic acid liposome (UAL), a new antitumor drug, has potential therapeutic value.
However, limited clinical data exists regarding multiple-dose safety, antitumor activity, and the recommended dose (RD) of UAL for subjects with advanced solid tumors.
All subjects were intravenously administered UAL for 14 consecutive days of a 21-day treatment cycle.
Twenty-one subjects were enrolled in 1 of 3 sequential cohorts (56, 74, and 98 mg/m2) to evaluate multiple-dose tolerability and efficacy.
Eight additional subjects were treated with UAL (74 mg/m2) to evaluate multiple-dose pharmacokinetics.
No ≥grade 3 adverse events (NCI-CTC) were observed.
Sixty percent subjects achieved stable disease after 2 treatment cycles.
Multiple-dose pharmacokinetic analysis suggested UAL does not accumulate in the body.
This trial demonstrates that UAL was tolerable, had manageable toxicity, and could potentially improve patient remission rates.
A large phase II study is recommended to confirm these results (i.e., RD of 98 mg/m2).
American Psychological Association (APA)
Qian, Zhengzi& Wang, Xianhuo& Song, Zheng& Zhang, Huilai& Zhou, Shiyong& Zhao, Jing…[et al.]. 2015. A Phase I Trial to Evaluate the Multiple-Dose Safety and Antitumor Activity of Ursolic Acid Liposomes in Subjects with Advanced Solid Tumors. BioMed Research International،Vol. 2015, no. 2015, pp.1-7.
https://search.emarefa.net/detail/BIM-1056810
Modern Language Association (MLA)
Qian, Zhengzi…[et al.]. A Phase I Trial to Evaluate the Multiple-Dose Safety and Antitumor Activity of Ursolic Acid Liposomes in Subjects with Advanced Solid Tumors. BioMed Research International No. 2015 (2015), pp.1-7.
https://search.emarefa.net/detail/BIM-1056810
American Medical Association (AMA)
Qian, Zhengzi& Wang, Xianhuo& Song, Zheng& Zhang, Huilai& Zhou, Shiyong& Zhao, Jing…[et al.]. A Phase I Trial to Evaluate the Multiple-Dose Safety and Antitumor Activity of Ursolic Acid Liposomes in Subjects with Advanced Solid Tumors. BioMed Research International. 2015. Vol. 2015, no. 2015, pp.1-7.
https://search.emarefa.net/detail/BIM-1056810
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1056810