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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RAD001
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, NSCLC, Advanced Lung Cancer, RAD, RAD001, chemotherapy, carboplatin, paclitaxel, bevacizumab

Eligibility Criteria

23 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114
  • LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
  • U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
  • MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc.
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Step 1 Arm 1

Step 1, Arm 2

Step 2, Arm 1

Step 2, Arm 2

Arm Description

5mg/day RAD001 + Carboplatin + Paclitaxel

30mg/week RAD001 + Carboplatin + Paclitaxel

5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab

30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab

Outcomes

Primary Outcome Measures

Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2007
Last Updated
February 9, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00457119
Brief Title
Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Non Small Cell Lung Cancer, NSCLC, Advanced Lung Cancer, RAD, RAD001, chemotherapy, carboplatin, paclitaxel, bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Step 1 Arm 1
Arm Type
Experimental
Arm Description
5mg/day RAD001 + Carboplatin + Paclitaxel
Arm Title
Step 1, Arm 2
Arm Type
Experimental
Arm Description
30mg/week RAD001 + Carboplatin + Paclitaxel
Arm Title
Step 2, Arm 1
Arm Type
Experimental
Arm Description
5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab
Arm Title
Step 2, Arm 2
Arm Type
Experimental
Arm Description
30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab
Intervention Type
Drug
Intervention Name(s)
RAD001
Other Intervention Name(s)
Everolimus
Intervention Description
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)
Time Frame
End of step 1
Title
Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)
Time Frame
End of Step 2
Title
PK parameters derived from PK profiles of treatment drugs alone and in combination
Time Frame
End of Step 1 and Step 2
Title
Best overall response - measured by CT/MRI scan every 6-8 week
Time Frame
Every 6-8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2197
Country
United States
Facility Name
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9151
Country
United States
Facility Name
MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Novartis Investigative Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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