A multicenter phase II study of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer

Phase 2

• Conditions: colorectal cancer

• Registration Number: JPRN-UMIN000031221
• Lead Sponsor: Aichi Cancer Center Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-26
• Study Completion: 2020-09-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmed objective response rate(ORR) by investigators' assessment

Secondary Outcome Measures

Name	Time	Method
Progression-free survival;PFS Duration of response;DoR Disease control rate;DC Overall survival;OS Incidences of adverse events