Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy
- Registration Number
- NCT00456833
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 248
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description erlotinib 150mg/day erlotinib - RAD 5mg/day + erlotinib RAD001 - erlotinib 150mg/day RAD001 -
- Primary Outcome Measures
Name Time Method Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose. first 28 days of combined treatment Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1 at baseline and after 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue Dec 2009 Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression at baseline, monthly until month 4 then q2months until progression Phase 2: Safety and steady state drug levels evaluated monthly Monthly
Trial Locations
- Locations (1)
Novartis Investigative Site
🇷🇺Moscow, Russian Federation