Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)



Status:Active, not recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/17/2016
Start Date:September 2014
End Date:August 2016

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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.

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.


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- Progression on standard therapies or withdrawn from standard treatment due to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

- - The remaining standard available therapy as recommended by investigator is best
supportive care (note: previous treatment with regorafenib and TAS 102 are allowed
and these agents should be administered before study if available to patient
according to local standards)

- - 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 partial
prothrombin Time (PTT) = 2xULN

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.
We found this trial at
15
sites
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