Unresectable, advanced or recurrent colorectal cancer with BRAF V600E mutation
Conditions
Sponsors
Bando Hideaki
Yoshino Takayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Unresectable adenocarcinoma of the colon or rectum (excluding appendiceal carcinoma and anal canal carcinoma) was diagnosed by histological examination 2. Wild-type RAS and BRAF V600E mutation in tumor tissue 3. The best overall response (RECIST Guidelines ver 1.1) was CR, PR, SD (>= 4 months), nonCR/nonPD (>= 4 months) for combination therapy including encorafenib and cetuximab 4. PD by imaging or clinical PD was confirmed within 4 weeks after the last dose of encolafenib 5. No history of MEK inhibitor administration 6. Participating in or planning to participate in the GOZILA trial 7. ECOG PS 0 or 1 8. Age on the date of consent >= 20 years old 9.Possible to take drugs orally 10.Applicable starting doses of encorafenib, binimetinib, and cetuximab as defined in this trial 11. Adequate organ function confirmed by laboratory values measured within 14 days before enrollment 12.Written consent obtained from the patient
Exclusion criteria
Exclusion criteria: 1. Patients have the following serious complications; a. Active double or more cancer b. Poorly controlled brain metastasis or leptomeningeal metastasis c. Active infections d. Ascites, pleural effusion or pericardial effusion requiring continuous drainage at the date of registration e. Uncontrolled diabetes mellitus or hypertension f. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (NYHA Class 3 or 4) within the previous 6 months from enrollment g. Patients with or at risk of previous or current retinal vein occlusion. h. Psychosis or psychiatric symptoms that make it difficult to participate in this study 2. The following therapy before first protocol treatment; a. Extensive surgery within 4 weeks b. Enterostomy within 2 weeks c. Any antineoplastic treatment within 2 weeks(Encolafenib, cetuximab, and 5-FU are acceptable) 3. Unrecovered adverse events from prior treatment 4. History of serious allergy to encorafenib or cetuximab 5. Severe lung disease 6. Pregnant, lactating, positive pregnancy test, or unwilling to prevent pregnancy 7. Gilbert syndrome or known UGT1A1*6/*6, UGT1A1*28/*28, UGT1A1*6/*28
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 12 weeks after first protocol treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) Objective response rate (ORR) Disease control rate (DCR) Time to treatment failure (TTF) Overall survival (OS) Rate of adverse events | — |
Contacts
Public ContactHideaki Bando
National Cancer Center Hospital East
Outcome results
None listed