Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Everolimus; Paclitaxel; Sirolimus

Criteria

Inclusion criteria:

• Age over 18 years

• Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)

• Ability to perform normal daily functions

Exclusion criteria:

• Chronic steroid treatment

• Prior treatment with chemotherapy for advanced lung cancer

• Prior treatment with mTOR inhibitors

• Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions

• Known sensitivity to platinum compounds, taxanes or bevacizumab

• Other cancers within the past 5 years

• Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply