A Phase 2 interventional study of regorafenib in Advanced Chemorefractory Colorectal Adenocarcinoma, sponsored by Jules Bordet Institute. Completed at 17 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-25.
Sponsored by Jules Bordet Institute · Phase 2, Interventional, and Treatment
The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms.
The primary objective is to identify in a population of patients bearing advanced, refractory colorectal cancers, those who draw no benefit from treatment with regorafenib. There is no specific hypothesis underlying sample size and the study is therefore to be seen as exploratory.
Secondary objectives:
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 141 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Jules Bordet Institute is the lead sponsor of 103 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants must have normal organ and bone marrow function as defined below:
Exclusion Criteria:
A treatment cycle is defined as a 4 weeks period. Regorafenib will be administered once a day orally at a dose of 160 mg (4 tablets of 40 mg), for 3 weeks.
Drug: regorafenib
Patients will receive 160 mg regorafenib 1/day 3 weeks out of 4.
Also known as: stivarga (registred name)
Overall survival (OS)
Time frame: 2 years from first patient in
Occurence of Adverse events
Assessment of safety will follow the WHO guidelines and classified according to NCI-CTCAE v. 4.0 and will be performed every 28 days until 28 days (safety follow up visit) after stopping therapy. Reasons for stopping therapy may include progression of disease or unbearable toxicities, or patient's decision.
Time frame: Every 28 days till 28 days after stopping therapy. An average of 2 months is expected.
Evaluation of tumour response
RECIST 1.1-based radiological assessment (CT or MRI) will be made every 2 cycles, starting at day 28 of the second cycle till demonstration of progressive disease. An average of 2 months is expected.
Time frame: Every 2 months till progression of the disease. An average of 2 months is expected.
Metabolic response assessed by FDG PET
FDGPET will be done twice during the study course : at baseline (at day 0, before treatment begin) and after 2 weeks.
Time frame: 2 FDGPET will be perfomed : at Baseline (day 0) and at D14
Molecular aberrations
Genetic, epigenetic and molecular aberrations will be investigated using gene expression profiling, RNA and exome sequencing, and methylation profiling on the tumor biopsies and repeated blood samples collected during the trial. The relationship between the molecular aberrations,the patient's outcome (PFS, OS) and with metabolic response after treatment with regorafenib will be studied.
Time frame: at day 0 (before treatment begins) and at D14, then repeated every 2 months until progression. An average of 2 months is expected.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jules Bordet Institute