A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

February 6, 2013

Primary Completion Date

February 24, 2015

Study Completion Date

May 11, 2022

Conditions
Breast Cancer
Interventions
DRUG

Eribulin

"Eribulin will be administered on days 1 and 8 slow IV push over 2 to 5 minutes. Premedications will be given per institutional guidelines.~Level 1: 0.9 mg/m\^2; Level 2: 1.1 mg/m\^2; Level 3: 1.4 mg/m\^2"

DRUG

Carboplatin

Carboplatin will be administered intravenously on day 1 and day 8 of each cycle, immediately following eribulin infusion at a dose of area-under-the-curve (AUC) 2 over 30 minutes in 250 ML of 0.9 % normal saline. Carboplatin dose will be calculated using the Calvert formula using AUC of 2 as follows: Carboplatin dose (mg) = 2 X (GFR + 25).

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT01795586 - A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients | Biotech Hunter | Biotech Hunter