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A Confirmation Study of Eribulin in Combination With Capecitabine

NCT01323530 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2021-01-11

Study results available
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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.

Conditions

Interventions

DRUG

Eribulin mesylate

Intravenous (IV) bolus or infusion.

DRUG

Capecitabine

Oral film-coated tablets.

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Bulgaria
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01323530 on ClinicalTrials.gov