OGSG2101:Efficacy and Safety of BEACON triplet regimen for early relapse BRAF-mutated colorectal cancer

JRCT ID: jRCTs051210152

Registered date:13/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: BRAF V600E-mutated colorectal cancer
• Date of first enrollment: 26/01/2022
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Encorafenib,binimetinib,cetuximab

Outcome(s)

• Primary Outcome: Objective response rate
• Secondary Outcome: Overall survival,Progression free survival, Disease control rate, Duration of response, Time to treatment failure, Rate of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically diagnosed adenocarcinoma of the colon or rectum (excluding appendiceal cancer and anal canal cancer)
2) Patients with RAS wild-type and BRAF V600E mutation proved by tumor tissue
3) Patients who received postoperative adjuvant chemotherapy after pStage II/III radical resection and meet any of the following criteria
a) Recurrence during adjuvant chemotherapy
b) Recurrence within 6 months after postoperative adjuvant chemotherapy due to adverse events
c) Recurrence within 6 months after scheduled adjuvant chemotherapy
4) No prior treatment with encorafenib, binimetinib, or cetuximab
5) Measurable lesions based on the RECIST v1.1
6) Performance Status (ECOG) 0-2
7) Age=>20 years
8) Patients who can take oral medication
9) Meet all of the following conditions
a) Neutrophil count=>1,200/mm3
b) Hemoglobin=> 9.0 g/dL (No blood transfusion within 14 days prior to registration)
c) Platelet count => 75,000/mm3
d) Total bilirubin =<2.0 mg/dL
e) ALT =<100 IU/L, AST =< 100 IU/L (=< 200 IU/L in patients with liver metastasis)
f) Serum creatinine =< 1.5 mg/dL or creatinine clearance calculated by the Cockcroft-Gault equation or measured directly is => 50 mL/min
10) Patients are expected to survive for at least 12 weeks
11) With written informed consent

Exclude criteria

1) Synchronous or metachronous active malignancies with a disease-free interval of 5 years or less
2) Symptomatic brain metastasis or meningitis
3) Women who are pregnant, breast feeding, or who wish to conceive. Men who wish to conceive
4) Unrecovered grade 2 or higher (CTCAE ver.5.0) AEs related to previous treatment (excluding anemia, alopecia, skin pigmentation, and oxaliplatin-induced peripheral neuropathy and proteinuria)
5) Patients with active infections (fever of 38 centigrade or higher)
6) History of myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) Class III or IV symptomatic congestive heart failure within the past 6 months from the date of enrollment
7) Poorly controlled hypertension with a systolic blood pressure of 150 mmHg or diastolic blood pressure of 100 mmHg or higher, even with medication
8) Poorly controlled active hepatitis B with detectable HBV-DNA despite the administration of nucleic acid analogs, active hepatitis C with positive HCV-RNA, or known HIV infection
9) Ascites, pleural effusion or pericardial effusion requiring continuous drainage on the date of enrollment
10) Patients with a history of, or currently suffering from, retinal vein occlusion, or at risk for such occlusion
11) Patients with concomitant psychosis or psychiatric symptoms that make it difficult to participate in clinical research
12) Patient treated with any of the following within a certain period of time prior to the start of protocol treatment
a) Extensive surgery within 4 weeks (excluding CV port placement)
b) Stoma surgery within 2 weeks
13) Other cases in which physicians judges that the subject is inappropriate for this clinical research

Related Information

• Primary Sponsor: KAGAWA Yoshinori
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.