Clinical tolerability and pharmacokinetics of troxacitabine / 中华肿瘤杂志
Chinese Journal of Oncology
; (12): 519-524, 2023.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-984752
Responsible library:
WPRO
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).
Full text:
Available
Database:
WPRIM (Western Pacific)
Main subject:
Prospective Studies
/
Maximum Tolerated Dose
/
Neoplasms
/
Neutropenia
/
Antineoplastic Agents
Limits:
Humans
Language:
Chinese
Journal:
Chinese Journal of Oncology
Year:
2023
Document type:
Article