A double-blind, randomised, placebo controlled Phase III study of nintedanib plus best supportive care (BSC) versus placebo plus BSC in patients with colorectal cancer refractory to standard therapies.
- Conditions
- bowel cancer10017991colorectal adenocarcinoma10017990
- Registration Number
- NL-OMON42006
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
- 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
- mECOG performance status * 1
At least one measurable lesion according to RECIST 1.1
- Progression on standard therapies or withdrawn from standard treatment due to
unacceptable toxicity. Previous standard treatment must include all of the following:
* * flouropyrimidine
* * 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 is allowed if available to
patient according to local standards as determined by investigator)
- Previous treatment with nintedanib.
- Known hypersensitivity to the trial drugs or their excipients.
- toxicity attributed to previous anticancer therapy that did not resolve to CTCAE grade *1 with exception of Hb, alopecia, pigmentation and oxaliplatin related neurotoxicity.
- History of severe haemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis). Known inherited predisposition to bleeding or to thrombosis.
- Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or
similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device is allowed)
- Inflammatory bowel disease and other serious medical conditions increasing the risk of perforation or bleeding according to investigator*s judgment.
- Gastrointestinal disorders or abnormalities that would interfere with absorption of study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Co-primary endpoints: progression-free survival (PFS) by central review<br /><br>assessment and overall survival (OS)</p><br>
- Secondary Outcome Measures
Name Time Method