NCT01515306

A Study of Ramucirumab (IMC-1121B) and Paclitaxel in Participants With Solid Tumors

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether there are no clinically significant pharmacokinetic effects of concomitant ramucirumab (IMC-1121B) on paclitaxel by investigating the pharmacokinetics (PK) of each in participants with advanced malignant solid tumors. Part A of this study will investigate the potential of concomitant ramucirumab (IMC-1121B) to affect the pharmacokinetics of paclitaxel. Part B of this study will investigate the pharmacokinetics of ramucirumab (IMC-1121B) as monotherapy.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	ramucirumab (IMC-1121B)	ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1and Day 15 of each 4-week cycle, unless otherwise specified.
DRUG	paclitaxel	paclitaxel 80 milligrams/square meter (mg/m²) intravenous infusion, administered on Days 1, 8 and 15 of each 4-week cycle, unless otherwise specified.

Timeline

• Start date: 2012-07-19
• Primary completion: 2013-03-20
• Completion: 2021-02-22
• First posted: 2012-01-24
• Last updated: 2022-03-08
• Results posted: 2014-06-18

Locations

6 sites across 1 country: United States