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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
768
Progression-Free Survival (PFS) by Central Review Assessment
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.
Time frame: From randomisation until cut-off date 14JUN2016.
Overall Survival (OS)
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.
Time frame: From randomisation until cut-off date 14JUN2016.
Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment
Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.
Time frame: From randomisation until cut-off date 14JUN2016.
Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment
Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).
Time frame: From randomisation until cut-off date 14JUN2016.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1199.52.0108 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1199.52.0105 Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States
1199.52.0101 Boehringer Ingelheim Investigational Site
Plainville, Connecticut, United States
1199.52.0121 Boehringer Ingelheim Investigational Site
Arlington Heights, Illinois, United States
1199.52.0123 Boehringer Ingelheim Investigational Site
Sioux City, Iowa, United States
1199.52.0104 Boehringer Ingelheim Investigational Site
Topeka, Kansas, United States
1199.52.0114 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
1199.52.0113 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
1199.52.0125 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
1199.52.0119 Boehringer Ingelheim Investigational Site
Johnson City, New York, United States
...and 119 more locations