At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 768 enrolled
Drug / intervention
Nintedanib (BIBF 1120) +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.
A Double-blind, Randomised, Placebo Controlled Phase III Study of Nintedanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies.
In Brief
A Phase 3 clinical trial evaluating Nintedanib (BIBF 1120), Placebo, and 1 other intervention for Colorectal Neoplasms. Completed, enrolled 768 participants across 129 sites in 25 countries.
Detailed Summary
The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasms
CountriesArgentina, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartSep 2014
Primary CompletionMay 2016
Study CompletionAug 2016
TodayJul 2026
First PostedMay 29, 2014
Enrollment StartSep 25, 2014
Primary CompletionMay 13, 2016
Study CompletionAug 25, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.1 years ago
Interventions
Nintedanib (BIBF 1120)drug
Placebodrug
BSCdrug
BSCdrug