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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00456833
First received: April 4, 2007
Last updated: April 12, 2012
Last verified: April 2012
  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:


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 April 16, 2014