A Phase I Trial to Evaluate the Multiple-Dose Safety and Antitumor Activity of Ursolic Acid Liposomes in Subjects with Advanced Solid Tumors.
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...
| Publicado en: | BioMed Research International Vol. 2015; pp. 1 - 8 |
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| Autores principales: | , , , , , , |
| Formato: | clinical trial research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
3/19/2015
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=109273707&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 109273707 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 23146133 FT2T jtl: BioMed Research International issn: 23146133 maglogo: N pubinfo: dt: 3/19/2015 vid: 2015 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 109273707 109273707 109273707 10.1155/2015/809714 109273707 ppf: 1 ppct: 7 formats: fmt: @attributes: type: P tig: atl: A Phase I Trial to Evaluate the Multiple-Dose Safety and Antitumor Activity of Ursolic Acid Liposomes in Subjects with Advanced Solid Tumors. aug: au: Qian, Zhengzi Wang, Xianhuo Song, Zheng Zhang, Huilai Zhou, Shiyong Zhao, Jing Wang, Huaqing affil: Department of Lymphoma, Sino-US Center for Lymphoma and Leukemia, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center of Cancer, Key Laboratory of Cancer Prevention and Therapy, Tiyuanbei, Huanhuxi Road, Hexi District, Tianjin 300060, China sug: subj: Neoplasms Drug Therapy Dosage Forms Terpenes Administration and Dosage Antineoplastic Agents Administration and Dosage Severity of Illness Indices Functional Status Terpenes Adverse Effects Antineoplastic Agents Adverse Effects Treatment Outcomes Terpenes Pharmacokinetics Clinical Assessment Tools Scales China Clinical Trials Descriptive Statistics Adult Middle Age Aged Female Male Human Funding Source Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Female Male ab: 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). pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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