Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients
- Registration Number
- NCT00466466
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daily dosing RAD001 Everolimus - Weekly dosing RAD001 Everolimus -
- Primary Outcome Measures
Name Time Method Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1 Day 21
- Secondary Outcome Measures
Name Time Method Overall tumor response Every 6-8 weeks Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen within 6 cycles (Day 126) PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles During the first 6 cycles
Trial Locations
- Locations (6)
Highlands Oncology Group
🇺🇸Fayetteville, Arkansas, United States
University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Dana Faber Cancer Institute
🇺🇸Boston, Massachusetts, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Cancer Therapy and Research Center at UTHSCSA
🇺🇸San Antonio, Texas, United States
Novartis Investigative Site
🇫🇷Paris, France
Highlands Oncology Group🇺🇸Fayetteville, Arkansas, United States