CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Capecitabine +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02393755
NCT02393755Phase 2Completed

A Phase I/II Study of Nintedanib and Capecitabine in Refractory Metastatic Colorectal Cancer

Roswell Park Cancer Institute·interventional·Posted Mar 19, 2015·Updated Jul 8, 2021

In Brief

A Phase 2 clinical trial evaluating Capecitabine, Laboratory Biomarker Analysis, and 2 other interventions for Colon Adenocarcinoma and 7 related conditions. Completed, enrolled 42 participants across 2 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 19, 2015
Enrollment StartMay 8, 2015
Primary CompletionNov 1, 2017
Study CompletionMay 18, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.3 years ago

Interventions

Capecitabinedrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Nintedanibdrug

Given PO

Pharmacological Studyother

Correlative studies