Oncotarget

Clinical Research Papers:

Puquitinib mesylate, an inhibitor of phosphatidylinositol 3-kinase p110δ, for treating relapsed or refractory non-Hodgkin’s lymphoma

Hang Yang _, Yu Wang, Jing Zhan, Yi Xia, Peng Sun, Xi-Wen Bi, Pan-Pan Liu, Zhi-Ming Li, Su Li, Ben-Yan Zou and Wen-Qi Jiang

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Oncotarget. 2015; 6:44049-44056. https://doi.org/10.18632/oncotarget.5833

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Abstract

Hang Yang1,2,*, Yu Wang1,2,*, Jing Zhan1,3, Yi Xia1,2, Peng Sun1,2, Xi-Wen Bi1,2, Pan-Pan Liu1,2, Zhi-Ming Li1,2, Su Li1,3, Ben-Yan Zou1,4, Wen-Qi Jiang1,2

1Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China

2Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China

3Clinical Trial Center, Sun Yat-sen University Cancer Center, Guangzhou 510060, China

4Nursing Department, Sun Yat-sen University Cancer Center, Guangzhou 510060, China

*These authors have contributed equally to this work

Correspondence to:

Wen-Qi Jiang, e-mail: jiangwq_sysuucc@163.com

Ben-Yan Zou, e-mail: zouby@sysucc.org.cn

Keywords: XC-302, PI3K pathway, non-Hodgkin lymphoma, safety and efficacy, pharmacokinetics

Received: July 20, 2015     Accepted: September 24, 2015     Published: October 17, 2015

ABSTRACT

Objectives: To determine the safety of Puquitinib Mesylate (XC-302), an oral inhibitor of phosphatidylinositol 3-kinase, in treating relapsed or refractory non-Hodgkin’s lymphoma (NHL).

Methods: Between October 2013 and July 2015, 21 patients from Sun Yat-sen University Cancer Center were treated twice daily on each day of a 28-day cycle (median number of cycles, 2; maximum, 20) with XC-302 at a post prandial dose of 25 mg, 37.5 mg, or 50 mg. Adverse events (AEs), AUClast and Cmax, response rates, and overall survival were assessed.

Results: Patients had received a median (range) of 1 (1 to 3) previous cancer treatments. At the latest follow-up, two patients were still benefitting from the study. The most common drug-related AEs were elevations in alanine transaminase (ALT, 14 of 21 patients) and aspartate transaminase (AST, 7 of 21 patients). Four patients, both in the-50-mg group, had dose-limiting toxicities, and therapy was discontinued in a fifth because of persistent abnormal liver function. The overall response rate was 2 of19. Serum concentrations of XC-302 increased in a dose-dependent pattern. Median progression-free survival in all patients was 1.9 (95% CI, 1.7 to 2.0) months.

Conclusion: XC-302 has an acceptable safety profile and offers potential therapeutic value to patients with relapsed or refractory non-Hodgkin lymphoma.


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