NCT00515697

A Study of Ramucirumab in Participants With Metastatic Renal Cell Carcinoma

Phase II Single Arm Study of IMC-1121B in Patients With Metastatic Renal Cell Carcinoma With Disease Progression on or Intolerance to Tyrosine Kinase Inhibitor Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether ramucirumab is effective treatment in participants with metastatic renal cell carcinoma who have developed progressive disease or become intolerant to tyrosine kinase inhibitor therapy.

Detailed description

The Primary objective is to determine the best objective response rate (ORR) of ramucirumab when administered to participants with metastatic renal cell carcinoma (RCC) whose disease has progressed during therapy with a tyrosine kinase inhibitor (TKI, sunitinib and/or sorafenib) or who have developed intolerance to these agents.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Ramucirumab	Ramucirumab is an injectable solution administered as an intravenous infusion over 1 hour at a dose of 8 mg/kg day 1 of every 14-day cycle.

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2007-08-14
• Last updated: 2014-06-18
• Results posted: 2014-06-18

Locations

11 sites across 1 country: United States