A Confirmation Study of Eribulin in Combination With Capecitabine

Phase 1/2 Completed 76 enrolled Eisai Inc.

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1b/2, multi-center, open-label, dose escalation (in 2 different dosing schedules \[1 and 2\]) and dose-confirmation study of eribulin administered in combination with capecitabine.

Timeline

Start: 2010-01-26
Primary completion: 2014-07-28
Completion: 2015-10-13

Publications

Twelves C, Anthoney A, Savulsky CI, Guo M, Reyderman L, Cresti N, Semiglazov V, Timcheva C, Zubairi I, Morrison R, Plummer R, Evans TRJ. A phase 1b/2, open-label, dose-escalation, and dose-confirmation study of eribulin mesilate in combination with capecitabine. Br J Cancer. 2019 Mar;120(6):579-586. doi: 10.1038/s41416-018-0366-5. Epub 2019 Feb 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Capecitabine	Small molecule	1250 mg/m2	Oral
Subject	Eribulin	Small molecule	0.7 mg/m2	Intravenous
Subject	Eribulin	Small molecule	1.1 mg/m2	Intravenous
Subject	Eribulin	Small molecule	1.2 mg/m2	Intravenous
Subject	Eribulin	Small molecule	1.4 mg/m2	Intravenous
Subject	Eribulin	Small molecule	1.6 mg/m2	Intravenous
Subject	Eribulin	Small molecule	1.7 mg/m2	Intravenous
Subject	Eribulin	Small molecule	2 mg/m2	Intravenous

A Confirmation Study of Eribulin in Combination With Capecitabine

Summary

Timeline

Publications

Drugs

Indications