A phase I trial to evaluate the multiple-dose safety and antitumor activity of ursolic acid liposomes in subjects with advanced solid tumors.
A phase I trial to evaluate the multiple-dose safety and antitumor activity of ursolic acid liposomes in subjects with advanced solid tumors.
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DOI：
10.1155/2015/809714
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发表时间：
2015
影响因子：
--
通讯作者：
Wang H
中科院分区：
文献类型：
--
作者：
Qian Z;Wang X;Song Z;Zhang H;Zhou S;Zhao J;Wang H
熊果酸脂质体(UAL)是一种新型抗肿瘤药物，具有潜在的治疗价值。然而，对于晚期实体瘤患者的多剂量安全性、抗肿瘤活性和UAL的推荐剂量(RD)，临床数据有限。所有受试者在21天的治疗周期中连续14天静脉注射UAL。21名受试者参加了3个序贯队列中的1个(56、74和98 mg/m2)，以评估多剂量耐受性和有效性。另外8名受试者接受UAL(74 mg/m2)治疗，以评估多剂量的药代动力学。未观察到≥3级不良事件。两个治疗周期后，60%的受试者病情稳定。多剂量药代动力学分析表明，UAL不会在体内蓄积。这项试验表明，UAL是可耐受的，毒性可控，并有可能提高患者缓解率。建议进行一项大型的第二阶段研究来证实这些结果(即，RD为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/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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影响因子：
5.4
作者：
Liu, H
通讯作者：
Liu, H
影响因子：
6.4
作者：
Harmand, PO;Duval, R;Simon, A
通讯作者：
Simon, A
DOI：
10.1073/pnas.88.24.11460
发表时间：
1991-12-01
影响因子：
11.1
作者：
PAPAHADJOPOULOS, D;ALLEN, TM;MARTIN, FJ
通讯作者：
MARTIN, FJ
影响因子：
2.3
作者：
Zhang, Ting;He, Yun-Mian;Xi, Tao
通讯作者：
Xi, Tao
影响因子：
5.2
作者：
Pathak, Ashutosh K.;Bhutani, Manisha;Aggarwal, Bharat B.
通讯作者：
Aggarwal, Bharat B.