drugset / Trial / NCT03213002

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

NCT03213002

Phase 1/2 Recruiting 67 enrolled Northwell Health
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.

Timeline

Start
2017-06-13
Primary completion
2028-06
Completion
2029-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1500 mg/m2 Oral
Subject Temozolomide Small molecule 150 mg/m2 Oral
Subject Temozolomide Small molecule 200 mg/m2 Oral