intedanib (BIBF 1120) vs placebo in refractory colorectal cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

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 = 1
- At least one measurable lesion according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
- Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. Previous standard treatment must include all of the following:
- - fluoropyrimidine
- - oxaliplatin: Patients treated with oxalipatin in adjuvant setting should have progressed within 6 months of completion of adjuvant therapy or they must have been treated with oxaliplatin for metastatic disease
- - irinotecan
- - bevacizumab or aflibercept
- - cetuximab or panitumumab for patients with K-Ras wt or Ras wt tumours
- - previous treatment with regorafenib is allowed
- - Life expectancy of at least 12 weeks
- - Hepatic function: aspartate aminotransferase (AST)/ Alanine Amino Tranferase (ALT) = 1.5 X Upper Limit of Normal (ULN) and bilirubin = ULN for patients without liver metastases. AST/ALT = 2.5 X ULN and bilirubin = ULN for patients with liver metastases. Patients with Gilbert syndrome and bilirubin < 2 X ULN and normal AST/ALT are eligible
- Coagulation parameters: International normalised ratio (INR) < 2 and prothrombin Time (PTT) = 2xULN

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 264

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: progression-free survival (PFS) by central review assessment and overall survival (OS);Timepoint(s) of evaluation of this end point: 1: 22 months<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1: Objective tumour response<br><br>2: Disease control<br>;Timepoint(s) of evaluation of this end point: 1: 22 months<br><br>2: 22 months<br><br>