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

February 9, 2013 updated by: Novartis Pharmaceuticals

A Two-step Phase 1 Study Investigating the Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients Not Treated Previously With Systemic Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Novartis Investigative Site
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Novartis Investigative Site
  • Germany
      • Essen, Germany, 45122
        • Novartis Investigative Site
      • Heidelberg, Germany, 69126
        • Novartis Investigative Site
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007-2197
        • Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390-9151
        • U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
      • Houston, Texas, United States, 77030-4009
        • MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Step 1 Arm 1
5mg/day RAD001 + Carboplatin + Paclitaxel
Drug: RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Other Names:
  • Everolimus
Experimental: Step 1, Arm 2
30mg/week RAD001 + Carboplatin + Paclitaxel
Drug: RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Other Names:
  • Everolimus
Experimental: Step 2, Arm 1
5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab
Drug: RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Other Names:
  • Everolimus
Experimental: Step 2, Arm 2
30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab
Drug: RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Other Names:
  • Everolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate
Time Frame: Ever 3 months or once a critical DLT occurs
Ever 3 months or once a critical DLT occurs

Secondary Outcome Measures

Outcome Measure
Time Frame
Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)
Time Frame: End of step 1
End of step 1
Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)
Time Frame: End of Step 2
End of Step 2
PK parameters derived from PK profiles of treatment drugs alone and in combination
Time Frame: End of Step 1 and Step 2
End of Step 1 and Step 2
Best overall response - measured by CT/MRI scan every 6-8 week
Time Frame: Every 6-8 week
Every 6-8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 9, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001C2114
  • 2006-002760-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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