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Status:

COMPLETED

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

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Non Small Cell Lung Cancer

Eligibility:

All Genders

23-76 years

Phase:

PHASE1

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 ...

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, paclit...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2009

    Estimated Enrollment :

    69 Patients enrolled

    Trial Details

    Trial ID

    NCT00457119

    Start Date

    February 1 2007

    End Date

    November 1 2009

    Last Update

    February 12 2013

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114

    Washington D.C., District of Columbia, United States, 20007-2197

    2

    LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center

    New Orleans, Louisiana, United States, 70115

    3

    U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

    Dallas, Texas, United States, 75390-9151

    4

    MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc.

    Houston, Texas, United States, 77030-4009