NCT01567163

A Study of Ramucirumab and Docetaxel in Participants With Solid Tumors

A Study to Evaluate the Potential of Concomitant Ramucirumab to Affect the Pharmacokinetics of Docetaxel in Patients With Advanced Malignant Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of concomitant ramucirumab on the pharmacokinetics of docetaxel in participants with advanced malignant solid tumors. Participants who do not complete both Cycle 1, Day 1, and Cycle 2, Day 1 according to schedule will be replaced for the purpose of analysis; these participants may continue to receive study therapy. No dose reductions, delayed or missed doses are allowed during Cycles 1 and 2.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Ramucirumab	ramucirumab 10 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1 of 3-week cycle
DRUG	Docetaxel	docetaxel 75 milligrams/square meter (mg/m\^2) intravenous infusion administered on Day 1 of each 3-week cycle

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-12-01
• Completion: 2014-03-01
• First posted: 2012-03-30
• Last updated: 2014-10-16
• Results posted: 2014-06-18

Locations

6 sites across 1 country: United States