A multi-center proof-of-concept phase2 study of encorafenib + binimetinib + cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000031857
- Lead Sponsor
- ational Cancer Center Hospital Eas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 36
Not provided
1.History of treatment with epidermal growth factor receptor (EGFR) inhibitors including anti-EGFR antibody drugs 2.History of treatment with BRAF inhibitors or MEK inhibitors 3.History of treatment with regorafenib 4.Symptomatic brain metastases or meningeal dissemination 5.Leptomeningeal disease 6.Medical history, current condition, or risk of retinal vein occlusion 7.Inadequately controlled diabetes requiring insulin therapy 8.Acute or chronic pancreatitis 9.Medical history of clinically significant cardiac diseases 10.Gastrointestinal function or gastrointestinal diseases that significantly interfere with absorption, distribution, metabolism, and excretion of the study drugs 11.No history of other malignant tumors within 3 years before the start of study treatment. In cases of lesions corresponding to carcinoma in situ and intramucosal carcinoma judged to be cured by local therapy, non-metastatic prostate cancer not requiring systemic therapy, and other solid cancers that do not require therapy or are not estimated to be adversely affected by the study treatment, patients will not be excluded from the study when the coordinating committee concludes after consultation that there is no effect on the patient's prognosis. 12.Medical history of thromboembolism within 6 months 13.Concurrent neuromuscular disorder that is associated with the potential of elevated CK 14.Previous treatment with any of the following, a.cyclical chemotherapy within a period of 14 days b.bevacizumab, aflibercept, or ramucirumab within 3 weeks c.biologic therapy (except bevacizumab, aflibercept, or ramucirumab), immunotherapy, marketed small molecular compounds, or non marketed investigational anticancer treatments within 4 weeks, or within a period 5fold the halflife (whichever is shorter) d.prior radiotherapy to 30% of bone marrow
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Confirmed objective response rate by investigators' assessment
- Secondary Outcome Measures
Name Time Method