Comparison of two strategies that use the same drugs but with inverted sequence for the treatment of patients with metastatic colorectal cancer who have failed in previous therapies.
- Conditions
- RAS and BRAF wild-type chemorefractory metastatic colorectal cancer patientsMedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002834-35-IT
- Lead Sponsor
- G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 214
Age = 18 years.
Histologically proven diagnosis of CRC.
At least one measurable lesion according to RECIST1.1
ECOG PS = 1.
mCRC previously treated for metastatic disease with, or not considered candidates for, fluoropyrimidine, oxaliplatin, irinotecan and anti-angiogenic monoclonal antibody (bevacizumab or aflibercept).
RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) and BRAF (V600E mutation) wt status of primary CRC or related metastasis (local laboratory assessment).
Previous first-line anti-EGFR-containing therapy producing at least a partial response or a stable disease = 6 months.
At least 4 months elapsed between the end of first-line anti-EGFR administration and screening.
At least one line of therapy between the end of first-line anti-EGFR administration and screening.
RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) and BRAF (V600E mutation) wt status of ct-DNA at screening (central laboratory assessment by means of IdyllaTM ctKRAS-NRAS-BRAF Mutation Test, Biocartis, Inc.).
Neutrophils = 1.5 x 109/L, Platelets =100 x 109/L, Hgb = 9 g/dl.
Total bilirubin = 1.5 fold the upper-normal limits (UNL), ASAT (SGOT) and/or ALAT (SGPT) = 2.5 x UNL (or <5 x UNL in the case of liver metastases), alkaline phosphatase = 2.5 x UNL (or < 5 x UNL in case of liver metastases).
Creatinine clearance = 50 mL/min or serum creatinine = 1.5 x UNL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
Previous treatment with regorafenib.
Radiotherapy to any site within 4 weeks before the study
Untreated brain metastases or spinal cord compression or primary brain tumours.
Evidence of bleeding diathesis or coagulopathy.
Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.
Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of study enrolment.
Any previous venous thromboembolism = NCI CTCAE Grade 4.
History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment.
Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method