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


Phase 1
18 Years
80 Years
Not Enrolling
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

first 28 days of combined treatment

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2111

NCT ID:

NCT00456833

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer
  • NSCLC
  • Advanced lung cancer
  • RAD
  • RAD001
  • erlotinib
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Novartis Investigative SiteChicago, Illinois  60612
Novartis Investigative siteNashville, Tennessee  37232
Novartis Investigative SiteBoston, Massachusetts  02115
Novartis Investigative SiteMadison, Wisconsin  53792
Novartis Investigative SiteAtlanta, Georgia  30342
Novartis Investigative SiteMinneapolis, Minnesota  55455
Novartis Investigative SiteDallas, Texas  75235-9179