Patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who had received and responded to a BRAF inhibitor-based treatment.
Conditions
Brief summary
Progression-free survival rate at 4 months (4-month PFS) according to RECIST V1.1 by Investigator assessment.
Detailed description
Objective Response Rate (ORR) according to RECIST V1.1 by Investigator assessment., Progression free survival (PFS) according to RECIST V1.1 by Investigator assessment., Overall survival (OS), Clinical efficacy based on the presence absence of acquired genomic mechanism of resistance detected in the NGS baseline to the rechallenge., Incidence and severity of adverse events (AEs), graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Change in clinical laboratory test parameters, vital signs, ECGs and echocardiogram/MUGA scans.
Interventions
DRUGENCORAFENIB
DRUGCETUXIMAB
Sponsors
Vall D Hebron Institute Of Oncology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 4 months (4-month PFS) according to RECIST V1.1 by Investigator assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) according to RECIST V1.1 by Investigator assessment., Progression free survival (PFS) according to RECIST V1.1 by Investigator assessment., Overall survival (OS), Clinical efficacy based on the presence absence of acquired genomic mechanism of resistance detected in the NGS baseline to the rechallenge., Incidence and severity of adverse events (AEs), graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Change in clinical laboratory test parameters, vital signs, ECGs and echocardiogram/MUGA scans. | — |
Countries
Spain
Outcome results
None listed