Lenalidomide and Paclitaxel in Advanced Solid Tumors
Status:
Unknown status
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
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