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...
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| Published in | BioMed research international Vol. 2015; no. 2015; pp. 1 - 7 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Cairo, Egypt
Hindawi Publishing Corporation
01.01.2015
John Wiley & Sons, Inc |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2314-6133 2314-6141 2314-6141 |
| DOI | 10.1155/2015/809714 |
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| Abstract | 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). |
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| AbstractList | 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). 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/m super(2) ) to evaluate multiple-dose tolerability and efficacy. Eight additional subjects were treated with UAL (74 mg/m super(2) ) to evaluate multiple-dose pharmacokinetics. No > or =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/m super(2) ). 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/m 2 ) to evaluate multiple-dose tolerability and efficacy. Eight additional subjects were treated with UAL (74 mg/m 2 ) 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/m 2 ). 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/m(2)) to evaluate multiple-dose tolerability and efficacy. Eight additional subjects were treated with UAL (74 mg/m(2)) 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/m(2)). 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/m(2)) to evaluate multiple-dose tolerability and efficacy. Eight additional subjects were treated with UAL (74 mg/m(2)) 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/m(2)).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/m(2)) to evaluate multiple-dose tolerability and efficacy. Eight additional subjects were treated with UAL (74 mg/m(2)) 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/m(2)). |
| Audience | Academic |
| Author | Zhou, Shiyong Wang, Xianhuo Song, Zheng Zhao, Jing Wang, Huaqing Qian, Zhengzi Zhang, Huilai |
| AuthorAffiliation | 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 |
| AuthorAffiliation_xml | – name: 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 |
| Author_xml | – sequence: 1 fullname: Wang, Huaqing – sequence: 2 fullname: Zhou, Shiyong – sequence: 3 fullname: Zhang, Huilai – sequence: 4 fullname: Song, Zheng – sequence: 5 fullname: Wang, Xianhuo – sequence: 6 fullname: Qian, Zhengzi – sequence: 7 fullname: Zhao, Jing |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25866811$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | Copyright © 2015 Zhengzi Qian et al. COPYRIGHT 2015 John Wiley & Sons, Inc. Copyright © 2015 Zhengzi Qian et al. Zhengzi Qian et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyright © 2015 Zhengzi Qian et al. 2015 |
| Copyright_xml | – notice: Copyright © 2015 Zhengzi Qian et al. – notice: COPYRIGHT 2015 John Wiley & Sons, Inc. – notice: Copyright © 2015 Zhengzi Qian et al. Zhengzi Qian et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. – notice: Copyright © 2015 Zhengzi Qian et al. 2015 |
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| Snippet | Ursolic acid liposome (UAL), a new antitumor drug, has potential therapeutic value. However, limited clinical data exists regarding multiple-dose safety,... |
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| SubjectTerms | Acids Adolescent Adult Aged Antimitotic agents Antineoplastic agents Antineoplastic Agents, Phytogenic - administration & dosage Antineoplastic Agents, Phytogenic - adverse effects Antineoplastic Agents, Phytogenic - pharmacokinetics Cancer Cancer therapies Care and treatment Clinical Study Clinical trials Drug delivery systems Drug dosages Drug therapy FDA approval Female Hematology Hospitals Humans Liposomes Lymphoma Male Methods Middle Aged Neoplasms - blood Neoplasms - drug therapy Neoplasms - mortality NMR Nuclear magnetic resonance Product development Studies Triterpenes - administration & dosage Triterpenes - adverse effects Triterpenes - pharmacokinetics Tumors Urine Ursolic Acid |
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| Title | A Phase I Trial to Evaluate the Multiple-Dose Safety and Antitumor Activity of Ursolic Acid Liposomes in Subjects with Advanced Solid Tumors |
| URI | https://search.emarefa.net/detail/BIM-1056810 https://dx.doi.org/10.1155/2015/809714 https://www.ncbi.nlm.nih.gov/pubmed/25866811 https://www.proquest.com/docview/1674722261 https://www.proquest.com/docview/1673078700 https://www.proquest.com/docview/1676359308 https://pubmed.ncbi.nlm.nih.gov/PMC4383362 |
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