drugset / Trial / NCT01256567

A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer

NCT01256567

Phase 1 Completed 7 enrolled Eli Lilly and Company
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to investigate the safety and tolerability of the anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in Japanese participants with metastatic, or locally advanced breast cancer, with the aim of confirming the recommended dose of ramucirumab drug product (DP) in combination with docetaxel.

Timeline

Start
2010-12
Primary completion
2012-11
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramucirumab Monoclonal antibody 10 mg/kg Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous

Indications