Clinical tolerability and pharmacokinetics of troxacitabine.
10.3760/cma.j.cn112152-20221011-00696
- Author:
Yan SONG
1
;
Cheng Xu CUI
1
;
Wen ZHANG
1
;
Yong Kun SUN
1
;
Lin YANG
1
;
Hua ZHOU
2
;
Hai Feng LIU
2
;
Ai Ping ZHOU
1
Author Information
1. Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
2. Beijing HebaBiz Biotechnology Co. Ltd/National and Region joint Engineering Center for Anticancer Drug Development, Beijing 102206, China.
- Publication Type:Journal Article
- Keywords:
Malignant tumor;
Pharmacokinetics;
Phase Ⅰ clinical study;
Troxacitabine
- MeSH:
Humans;
Antineoplastic Agents/adverse effects*;
Maximum Tolerated Dose;
Neoplasms/drug therapy*;
Neutropenia/chemically induced*;
Prospective Studies
- From:
Chinese Journal of Oncology
2023;45(6):519-524
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To investigate the safety and efficacy of troxatabine in advanced or relapsed malignant tumors resistant to standard therapy in China. Methods: This is a phase Ⅰ prospective study. During dose escalation, patients in Cancer Hospital, Chinese Academy of Medical Sciences received a single-dose intravenous infusion of troxacitabine. The planned dosing groups were 1.8, 3.6, 4.8, 6.4 and 8.0 mg/m(2) on days 1 and 8 every 3 weeks. The data of all patients were collected for safety analyses. Safety and tolerability were evaluated by monitoring adverse events. Results: Nineteen patients were enrolled from April 2018 to May 2019. The major adverse events were fatigue (89.5%, 17/19), leukopenia (84.2%, 16/19) and neutropenia (78.9%, 15/19). The dose limiting toxicity was neutropenia. The maximum tolerated dose was 6.4 mg/m(2). The best effect was stable disease (43.8%). The half-life of elimination phase from 15.91 hours to 76.63 hours in each dose group. Conclusions: The toxicity of troxacitabine is well tolerant. We recommend that the dose for Phase Ⅱ clinical trial should be 6.4 mg/m(2).
