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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 768
- Locations
- 129
- Primary Endpoint
- Progression-Free Survival (PFS) by Central Review Assessment
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Nintedanib (BIBF 1120) + BSC
Intervention: Nintedanib (BIBF 1120) (Drug)
Nintedanib (BIBF 1120) + BSC
Intervention: BSC (Drug)
Placebo + BSC
Intervention: Placebo (Drug)
Placebo + BSC
Intervention: BSC (Drug)
Outcomes
Primary Outcomes
Progression-Free Survival (PFS) by Central Review Assessment
Time Frame: From randomisation until cut-off date 14JUN2016.
PFS by central review assessment was defined as the time from the date of randomisation to the date of disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or death from any cause, whichever occurred first. Median, 95% Confidence Interval were calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Overall Survival (OS)
Time Frame: From randomisation until cut-off date 14JUN2016.
OS was defined as the time from randomisation to the time of death from any cause. Median, 95% Confidence Interval were calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Secondary Outcomes
- Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment(From randomisation until cut-off date 14JUN2016.)
- Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment(From randomisation until cut-off date 14JUN2016.)