At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed malignant solid tumor
- ✓Advanced solid tumor refractory to standard therapy or no standard therapy available
- ✓Part A: 0-1 prior taxane regimens completed ≥6 months prior; Part B: prior bevacizumab and taxane regimens allowed if completed ≥6 months prior
- ✓Resolution to Grade ≤1 of all toxic effects from prior therapy except peripheral neuropathy which must be Grade ≤1
- ✕Concomitant therapy with CYP2C8 or CYP3A4 inhibitors or inducers
- ✕Enrolled in another clinical trial with investigational drug within 14 days
- ✕Monoclonal antibody received within 42 days prior
- ✕Radiotherapy within 14 days prior
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Potential of Concomitant Ramucirumab to Affect the Pharmacokinetics of Paclitaxel in Patients With Advanced Malignant Solid Tumors
In Brief
A Phase 2 clinical trial evaluating ramucirumab (IMC-1121B) and paclitaxel for Malignant Solid Tumor. Completed, enrolled 48 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1and Day 15 of each 4-week cycle, unless otherwise specified.
paclitaxel 80 milligrams/square meter (mg/m²) intravenous infusion, administered on Days 1, 8 and 15 of each 4-week cycle, unless otherwise specified.