colorectal cancer
Conditions
Interventions
Eribulin 1.4 mg/m2 days 1 and 8 (repeated every 21 days)
Sponsors
Aichi Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically proven adenocarcinoma of colorectal cancer (2) BRAF V600E mutant (3) Unresectable metastatic colorectal cancer (4) Refractory or intolerable to fluoropyrimidine-based first-line chemotherapy (5) ECOG Performance Status of 0 or 1 (6) >=20 and <=75 years old (7) With measureable disease according to RECIST version1.1 (8) Adequate organ function (9) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Symptomatic brain, pia mater, or meningeal metastasis (2) Active infection (3) Interstitial pneumonia or pulmonary fibrosis (4) Serious complications (renal failure, liver failure, severe cardiac disease, uncontrolled diabetes, uncontrolled hypertension, ileus, cerebral infarction, cerebral hemorrhage) (5) Massive pleural, abdominal, or pericardial effusion with continuous drainage (6) Active gastrointestinal hemorrhage (7) Clinically significant mental disorder (8) Previous treatment with eribulin (9) Women who are pregnant or patients who are unwilling to avoid pregnancy (10) Patients who are inappropriate for the study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival; PFS Time to treatment failure; TTP Overall survival; OS Disease control rate; DCR Safety | — |
Countries
Japan
Contacts
Public ContactToshiki Masuishi
Aichi Cancer Center Hospital Department of Clinical Oncology
Outcome results
None listed