A poilot study of eribulin monotherapy in chemorefractory patients with BRAF V600E-mutant metastatic colorectal cancer
Not Applicable
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000027648
- Lead Sponsor
- Aichi Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate; ORR
- Secondary Outcome Measures
Name Time Method Progression-free survival; PFS Time to treatment failure; TTP Overall survival; OS Disease control rate; DCR Safety