Overview

Dose-finding Study of CAELYXTM and RAD001 in Patients With Advanced Solid Tumors

Status:
Unknown status
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the Maximum Tolerated Dose (MTD) and the Recommended Dose (RD) of the combination RAD001 (escalating daily dose) and CaelyxTM (fixed dose) to patients with advanced solid tumors. Other purposes of the study are: 1. define the safety profile of the combination after repeated administrations 2. define hints of antitumor activity, to be confirmed in subsequent disease-oriented expansion phases at the RD. 3. define the pharmacokinetic profile of the combination
Phase:
Phase 1
Details
Lead Sponsor:
Southern Europe New Drug Organization
Collaborators:
Novartis
Schering-Plough
Treatments:
Everolimus
Sirolimus