drugset / Trial / NCT02393755

Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer

NCT02393755

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of nintedanib when given together with capecitabine and to see how well they work in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nintedanib with capecitabine may be a better treatment for colorectal cancer.

Timeline

Start
2015-05-08
Primary completion
2017-11-01
Completion
2021-05-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Nintedanib Small molecule 200 mg Oral