A randomized phase II study of gemcitabine plus Z-360, a CCK2 receptor-selective antagonist, in patients with metastatic pancreatic cancer as compared with gemcitabine plus placebo

作者：Ueno Makoto^*; Li Chung Pin; Ikeda Masafumi; Ishii Hiroshi; Mizuno Nobumasa; Yamaguchi Taketo; Ioka Tatsuya; Oh Do Youn; Ichikawa Wataru; Okusaka Takuji; Matsuyama Yutaka; Arai Daichi; Chen Li Tzong; Park Young Suk; Furuse Junji

来源：Cancer Chemotherapy and Pharmacology, 2017, 80(2): 307-315.

DOI：10.1007/s00280-017-3351-4

• Clinical trial
• Phase II
• Pancreatic cancer
• Metastatic

Background We investigated the efficacy and safety of 60, 120, or 240 mg of Z-360, which is a highly potent chol-ecystokinin2-receptor-selective antagonist, combined with gemcitabine in patients with metastatic pancreatic cancer.
Methods Patients were randomly assigned in a 1: 1: 1: 1 ratio to one of four treatment groups. Patients received 1000 mg/m(2) gemcitabine for each cycle and Z-360 tablets of 60 mg (GZ 60 mg group), 120, 240 mg or placebo tablets (Gem group) orally twice daily. The primary endpoint was overall survival (OS).
Results The median OS was 1.3 months longer in the GZ 60 mg group compared with the Gem group (8.5 vs. 7.2 months) and the risk of death was reduced by 19% compared with the Gem group, although there were no statistically significant differences. The study treatments were well tolerated.
Conclusions In this Phase II study, no statistically significant differences between the GZ groups and Gem group were detected in any analysis. However, Z-360 in dose of 60 mg tends to improve OS in patients with metastatic pancreatic cancer with low toxic effect. Further exploratory trials with other agents such as gemcitabine plus nab-paclitaxel might be beneficial.

• 出版日期2017-8
• 单位中国医学科学院肿瘤医院