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

Purpose

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.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: RAD001 Drug: erlotinib	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Sirolimus Everolimus Temsirolimus Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Novartis:

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. [ Time Frame: first 28 days of combined treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Phase 2: Safety and steady state drug levels evaluated monthly [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue [ Time Frame: Dec 2009 ] [ Designated as safety issue: No ]

Enrollment:	248
Study Start Date:	June 2005
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RAD 5mg/day + erlotinib	Drug: RAD001
Active Comparator: erlotinib 150mg/day	Drug: RAD001 Drug: erlotinib

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456833

Locations

United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30322
United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60637-1470
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02115
United States, Minnesota
Novartis Investigative Site
Rochester, Minnesota, United States, 55905
United States, Tennessee
Novartis Investigative Site
Nashville, Tennessee, United States, 37203
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77030-4009
United States, Wisconsin
Novartis Investigative Site
Madison, Wisconsin, United States, 53792
Canada, British Columbia
Novartis Investigative Site
Richmond, British Columbia, Canada, V7C 5L9
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2L 4M1
Denmark
Novartis Investigative Site
Herlev, Denmark, DK-2730
France
Novartis Investigative Site
Saint-Herblain Cédex, France, 44805
Novartis Investigative Site
Villejuif Cedex, France, 94805
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 115478

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals
Study Director:	Novartis Pharmaceuticals	Novartis Pharmeceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00456833 History of Changes
Other Study ID Numbers:	CRAD001C2111, 2004-003017-16
Study First Received:	April 4, 2007
Last Updated:	April 12, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:

Non Small Cell Lung Cancer
NSCLC
Advanced lung cancer

RAD
RAD001
erlotinib

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Sirolimus
Everolimus
Erlotinib

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013