Patients with metastatic colorectal cancer refractory to standards therapies MedDRA version: 17.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Nintedanib 100 mg soft capsules
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Concentration unit: mg milli
Sponsors
SCS Boehringer Ingelheim Comm.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Signed informed consent - Histologically or cytologically confirmed colorectal adenocarcinoma - Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy - Eastern Cooperative Oncology Group (ECOG) performance status ==65 years) yes F.1.3.1 Number of subjects for this age range 264
Exclusion criteria
Exclusion criteria: - Previous treatment with nintedanib - toxicity attributed to previous anticancer therapy that did not resolve to Common Terminology Criteria for Adverse Events (CTCAE) grade =<1 - History of other malignancies in the last 5 years, in particular those that could interfere with interpretation of results. - Serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, - Significant cardiovascular diseases - History of severe haemorrhagic or thromboembolic event in the past 12 months - Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic INR monitoring - Gastrointestinal disorders or abnormalities that would interfere with absorption of study drug - Patient with brain metastases that are symptomatic and/or require therapy. - Patients of childbearing potential who are sexually active and unwilling to use a highly effective method of contraception - Pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this Phase III study is to evaluate the efficacy and safety of nintedanib in patients with mCRC after failure of previous treatment with standard chemotherapy and biological agents.;Secondary Objective: Secondary objectives are Objective tumour response, disease control, quality of life and safety.;Primary end point(s): Co-primary endpoints:s progression free survival (PFS) by central review assessment and overall survival (OS) ;Timepoint(s) of evaluation of this end point: 1: 22 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Objective tumour response 3: Disease control ;Timepoint(s) of evaluation of this end point: 1: 22 months 2: 22 months | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Luxembourg, Mexico, Netherlands, Poland, Portugal, Russian Federation, Singapore, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed