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Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer

NCT02393755 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-07-08

Study results available
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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.

Conditions

  • Colon Adenocarcinoma
  • Rectal Adenocarcinoma
  • Recurrent Colon Carcinoma
  • Recurrent Rectal Carcinoma
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer

Interventions

DRUG

Capecitabine

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Nintedanib

Given PO

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Christos Fountzilas · Roswell Park Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02393755 on ClinicalTrials.gov