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

NCT ID: NCT00457119

Last Updated: 2013-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-11-30

Brief Summary

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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

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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

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Step 1 Arm 1

5mg/day RAD001 + Carboplatin + Paclitaxel

Group Type EXPERIMENTAL

RAD001

Intervention Type DRUG

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

Step 1, Arm 2

30mg/week RAD001 + Carboplatin + Paclitaxel

Group Type EXPERIMENTAL

RAD001

Intervention Type DRUG

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

Step 2, Arm 1

5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab

Group Type EXPERIMENTAL

RAD001

Intervention Type DRUG

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

Step 2, Arm 2

30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab

Group Type EXPERIMENTAL

RAD001

Intervention Type DRUG

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

Interventions

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RAD001

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

Intervention Type DRUG

Other Intervention Names

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Everolimus

Eligibility Criteria

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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
Minimum Eligible Age

23 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114

Washington D.C., District of Columbia, United States

Site Status

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

New Orleans, Louisiana, United States

Site Status

U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

Dallas, Texas, United States

Site Status

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

Houston, Texas, United States

Site Status

Novartis Investigative Site

Adelaide, South Australia, Australia

Site Status

Novartis Investigative Site

Heidelberg, Victoria, Australia

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Countries

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United States Australia Germany

Other Identifiers

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2006-002760-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRAD001C2114

Identifier Type: -

Identifier Source: org_study_id

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