Lenalidomide and Paclitaxel in Advanced Solid Tumors

Summary

This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the maximum Tolerated Dose (MTD) of the combination of CC-5013 (Lenalidomide)and paclitaxel in patients with advanced solid tumors. Other purposes of the study are: 1. Define the safety profile of the CC-5013 and paclitaxel given in combination 2. Define the pharmacokinetics of CC-5013 and paclitaxel given in combination 3. Define the pharmacodynamic effects of the combination by monitoring potential biomarkers of the different biological activities of each component of the regimen 4. Define the optimal biological dose (OBD) and the dose recommended (RD) for phase II studies in selected tumor types (breast, ovary, prostate, NSCLC) 5. Collect evidence of antitumor activity in selected tumor types

Timeline

Start

2009-11

Primary completion

2011-12

Completion

2012-03

Drugs

Indications