NCT00457119

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2007

Typical duration for phase_1

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

2.8 years

First QC Date

April 4, 2007

Last Update Submit

February 9, 2013

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung CancerNSCLCAdvanced Lung CancerRADRAD001chemotherapycarboplatinpaclitaxelbevacizumab

Outcome Measures

Primary Outcomes (1)

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

    Ever 3 months or once a critical DLT occurs

Secondary Outcomes (4)

  • Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)

    End of step 1

  • Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)

    End of Step 2

  • PK parameters derived from PK profiles of treatment drugs alone and in combination

    End of Step 1 and Step 2

  • Best overall response - measured by CT/MRI scan every 6-8 week

    Every 6-8 week

Study Arms (4)

Step 1 Arm 1

EXPERIMENTAL

5mg/day RAD001 + Carboplatin + Paclitaxel

Drug: RAD001

Step 1, Arm 2

EXPERIMENTAL

30mg/week RAD001 + Carboplatin + Paclitaxel

Drug: RAD001

Step 2, Arm 1

EXPERIMENTAL

5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab

Drug: RAD001

Step 2, Arm 2

EXPERIMENTAL

30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab

Drug: RAD001

Interventions

RAD001DRUG

5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm

Also known as: Everolimus
Step 1 Arm 1Step 1, Arm 2Step 2, Arm 1Step 2, Arm 2

Eligibility Criteria

Age23 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114

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

Location

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

New Orleans, Louisiana, 70115, United States

Location

U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

Dallas, Texas, 75390-9151, United States

Location

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

Houston, Texas, 77030-4009, United States

Location

Novartis Investigative Site

Adelaide, South Australia, 5000, Australia

Location

Novartis Investigative Site

Heidelberg, Victoria, 3084, Australia

Location

Novartis Investigative Site

Essen, 45122, Germany

Location

Novartis Investigative Site

Heidelberg, 69126, Germany

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

February 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations

DE(2)AU(2)US(4)