CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
Ramucirumab +1 morebiological
Likely dose
Ramucirumab 10 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01256567
NCT01256567Phase 1Completed
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A Phase 1b Study of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product in Patients With Locally Advanced or Metastatic Breast Cancer

Eli Lilly and Company·interventional·Posted Dec 8, 2010·Updated Jun 18, 2014

In Brief

A Phase 1 clinical trial evaluating Ramucirumab and Docetaxel for Breast Cancer and Metastatic Breast Cancer. Completed, enrolled 7 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Metastatic Breast Cancer
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2010
Enrollment StartDec 1, 2010
Primary CompletionNov 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.6 years ago

Interventions

Ramucirumabbiological

Ramucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.

Docetaxeldrug

Docetaxel administered by intravenous (I.V.) infusion at a dose of 75 milligrams per square meter (mg/m\^2) every 3 weeks.