Conditions: Metastatic Breast Cancer
Keywords: metastatic breast cancer
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 76
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants with advanced and/or metastatic tumors will receive eribulin mesylate as a 2 to 5 min Intravenous (IV) bolus or infusion in two different schedules (Schedule 1 \[1.2, 1.6, 2.0 mg/m2\], given on Day 1 only, and Schedule 2 \[0.7, 1.1, 1.7 mg/m\^2\], given on Days 1 and 8) and oral capecitabine 1000 mg/m2 bid on Days 1-14 (21-day cycles) in both schedules. If maximum tolerated dose (MTD) is not observed at dose level 3 the dose of capecitabine might be escalated to 1250 mg/m\^2 bid on Days 1-14 (21-day cycles) depending on the Dose limiting toxicities (DLTs) observed and/or pharmacokinetic (PK) data when available. Based on the data and safety monitoring board review of dose escalation phase data (DLTs that will be observed in first cycle), Dose-Confirmation Phase (Phase 2) will may get initiated. arm 2: Participants with advanced and/or metastatic tumors will receive Eribulin mesylate at the MTD for the selected schedule of dose escalation phase based on safety/PK data.

Interventions: intervention 1: Eribulin mesylate intervention 2: Capecitabine
Intervention descriptions: intervention 1: Intravenous (IV) bolus or infusion. intervention 2: Oral film-coated tablets.

Protocol document: