Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients
- Registration Number
- NCT00457119
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab
- Detailed Description
This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001 is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Step 1 Arm 1 RAD001 5mg/day RAD001 + Carboplatin + Paclitaxel Step 1, Arm 2 RAD001 30mg/week RAD001 + Carboplatin + Paclitaxel Step 2, Arm 2 RAD001 30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab Step 2, Arm 1 RAD001 5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab
- Primary Outcome Measures
Name Time Method Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate Ever 3 months or once a critical DLT occurs
- Secondary Outcome Measures
Name Time Method Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1) End of step 1 Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2) End of Step 2 PK parameters derived from PK profiles of treatment drugs alone and in combination End of Step 1 and Step 2 Best overall response - measured by CT/MRI scan every 6-8 week Every 6-8 week
Trial Locations
- Locations (5)
Novartis Investigative Site
🇩🇪Heidelberg, Germany
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
🇺🇸Dallas, Texas, United States
MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc.
🇺🇸Houston, Texas, United States
Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114
🇺🇸Washington, District of Columbia, United States
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
🇺🇸New Orleans, Louisiana, United States