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

Completed · Phase 1

Conditions studied: Non Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT00457119

Run by

Novartis Pharmaceuticals

People needed

69

Starts

2007-02-01

Expected to finish

2009-11-01

Last updated by the study team

2013-02-12

Who can join

Age: 23 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age over 18 years
• Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)
• Ability to perform normal daily functions

You may not qualify if…

• 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

Where it is running

• Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114 — Washington D.C., District of Columbia, United States
• LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center — New Orleans, Louisiana, United States
• 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
• Novartis Investigative Site — Adelaide, South Australia, Australia
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Heidelberg, Germany

Full record on ClinicalTrials.gov

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