colorectal cancer
Conditions
Interventions
Eribulin is administered intravenously at a dose of 1.4mg/m^2/day on Days 1 and 8, repeated every 21 days.
Sponsors
Aichi Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent 2.Age of 20 years or older 3.Confirmed diagnosis of metastatic colorectal cancer (mCRC) by tissue diagnosis 4.Refractory or tolerate to at least one regimen (including irinotecan or oxaliplatin) containing fluoropyrimidine for mCRC 5.BRAF V600E mutant CRC 6.Measurable lesions according to RECIST version 1.1 7.Being able to provide FFPE colorectal cancer tissue 8.PS:0-1 9.Life expectancy of 3 months or longer 10.Adequate organ function 11.Women of childbearing potential who are negative in a urine pregnancy test and agree to take appropriate precautions to avoid pregnancy from screening through 90 days after the final administration of eribulin
Exclusion criteria
Exclusion criteria: 1.History of treatment with eribulin 2.Symptomatic brain metastases or meningeal dissemination 3.Leptomeningeal disease 4.Medical history of clinically significant cardiac diseases 5.History of other malignant tumors within 3 years before the start of study treatment. 6.Previous treatment with any of the following: a.Last dose of cytotoxic agents or regorafenib within 14 days b.Last dose of cetuximab, panitumumab, bevacizumab, aflibercept, or ramucirumab within 3 weeks c.Last dose of biologic therapy (except cetuximab, panitumumab, bevacizumab, aflibercept, or ramucirumab), immunotherapy, non-marketed investigational anticancer treatments within 4 weeks d.Prior radiotherapy to 30% of bone marrow e.Major surgery within 2 weeks 7.Known HIV infection 8.Positive HBs antigen 9.Diagnosed as liver cirrhosis 10.Female patients who are breastfeeding 11.Other medically important abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed objective response rate(ORR) by investigators' assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;PFS Duration of response;DoR Disease control rate;DC Overall survival;OS Incidences of adverse events | — |
Countries
Japan
Contacts
Public ContactToshiki Masuishi
Aichi Cancer Center Hospital Department of Clinical Oncology
Outcome results
None listed