drugset / Trial / NCT03204032

A Study of Tegafur Combined With Temozolomide Versus Tegafur Combined With Temozolomide and Thalidomide in Subjects With Advanced Extrapancreatic Neuroendocrine Tumor

NCT03204032 ↗

Phase 2 Unknown 60 enrolled Chinese Academy of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

A Phase II Randomized,Controlled,Open Label,Multicentre Study to evaluate the efficacy and safety of Tegafur combined with Temozolomide versus Tegafur combined with Temozolomide and Thalidomide in subjects with Advanced Extrapancreatic Neuroendocrine Tumor

Timeline

Start
2016-10
Primary completion
2017-10
Completion
2018-09

Outcome

Missed primary endpoint

paper 26·1% [95% CI 17·2-37·5] versus 25·4% [95% CI 16·7-36·6]; odds ratio: 1·03 [95% CI 0·48-2·22]; P = 0·9381). PMID 36188432 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tegafur Unknown 40 mg Oral
Subject Tegafur Unknown 60 mg Oral
Subject Temozolomide Small molecule 200 mg Oral
Comparator Thalidomide Other / unclassified 300 mg Oral