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Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC)

NCT02389764 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-07-17

Study results available
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Summary

The goal of this clinical research study is to learn if Ofev® (nintedanib, also called BIBF1120) can help to control IBC. The safety of this drug will also be studied.

This is an investigational study. Nintedanib is commercially available and FDA approved for the treatment of certain types of lung disease. Its use in this study is investigational. The study doctor can explain how the study drug is designed to work.

Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

Interventions

DRUG

BIBF 1120

Initial dose is 200 mg twice daily orally for a 28 day cycle.

BEHAVIORAL

Phone Call

Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. These calls should last about 2 minutes.

Sponsors & Collaborators

Principal Investigators

  • Naoto Ueno, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-22
Primary Completion
2018-06-08
Completion
2019-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT02389764 on ClinicalTrials.gov