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Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

RAD001

erlotinib

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, erlotinib

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Age over 18 years
Advanced Non Small Cell Lung Cancer which is not responding to chemotherapy treatment including either cisplatin or carboplatin
Only 1-2 previous chemotherapy regimens for advanced disease
More than 2 weeks from previous surgery, radiation or chemotherapy
Ability to perform normal daily functions

Exclusion criteria:

Chronic steroid treatment
Prior treatment with EGFR inhibitors
Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions or other severe medical conditions
Other cancers within the past 2 years
Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RAD 5mg/day + erlotinib

erlotinib 150mg/day

Arm Description

Outcomes

Primary Outcome Measures

Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.

Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1

Secondary Outcome Measures

Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression

Phase 2: Safety and steady state drug levels evaluated monthly

Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue

Full Information

NCT ID

NCT00456833

First Posted

April 4, 2007

Last Updated

December 17, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00456833

Brief Title

Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy

Official Title

A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.

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, erlotinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

248 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RAD 5mg/day + erlotinib

Arm Type

Experimental

Arm Title

erlotinib 150mg/day

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

RAD001

Intervention Type

Drug

Intervention Name(s)

erlotinib

Primary Outcome Measure Information:

Title

Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.

Time Frame

first 28 days of combined treatment

Title

Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1

Time Frame

at baseline and after 8 weeks of treatment

Secondary Outcome Measure Information:

Title

Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression

Time Frame

at baseline, monthly until month 4 then q2months until progression

Title

Phase 2: Safety and steady state drug levels evaluated monthly

Time Frame

Monthly

Title

Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue

Time Frame

Dec 2009

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Age over 18 years Advanced Non Small Cell Lung Cancer which is not responding to chemotherapy treatment including either cisplatin or carboplatin Only 1-2 previous chemotherapy regimens for advanced disease More than 2 weeks from previous surgery, radiation or chemotherapy Ability to perform normal daily functions Exclusion criteria: Chronic steroid treatment Prior treatment with EGFR inhibitors Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions or other severe medical conditions Other cancers within the past 2 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

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmeceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637-1470

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

Facility Name

Novartis Investigative Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

British Columbia

ZIP/Postal Code

V7C 5L9

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Novartis Investigative Site

City

Herlev

ZIP/Postal Code

DK-2730

Country

Denmark

Facility Name

Novartis Investigative Site

City

Saint-Herblain Cédex

ZIP/Postal Code

44805

Country

France

Facility Name

Novartis Investigative Site

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5703

Description

Results for CRAD001C2111 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy

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Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy

Non Small Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial