An open-labeled, randomized, multicenter phase Ⅱa study of gambogic acid injection for a

An open-labeled, randomized, multicenter phase Ⅱa study of gambogic acid injection for advanced

malignant tumors

CHI Yihebali;ZHAN Xiao-kai;YU Hao;XIE Guang-ru;WANG Zhen-zhong;XIAO Wei;WANG Yong-gang

【期刊名称】《中华医学杂志（英文版）》 【年(卷),期】2013(126)009

【摘要】Background Gambogic acid is a pure active compound isolated from the traditional Chinese medicinal plant gamboge (Garcinia morella Desv.).Based on the preliminary results of a phase I study,this phase Ila study compared the efficacy and safety of different dosage schedules of gambogic acid in patients with advanced malignant tumors.Methods Patients with advanced or metastases cancer who had not received any effective routine conventional treatment or who had failed to respond to the existing conventional treatment were randomly assigned to receive either 45 mg/m2 gambogic acid intravenously from Days 1 to 5 of a 2-week cycle (Group A),or 45 mg/m2 every other day for a total of five times during a 2-week cycle (Group B).The primary endpoint was objective response rate (ORR).Results Twenty-one patients assigned to Group A and 26 to Group B were included in the final analysis.The ORRs were 14.3％ in Group A and 0％ in Group B.It was not possible to analyze the significant difference because one of the values was