Clinical trial NCT00456833: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
NSCLC
Advanced lung cancer
RAD
RAD001
erlotinib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-04-05
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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.
timeFrame: first 28 days of combined treatment
measure: 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
timeFrame: at baseline and after 8 weeks of treatment
Secondary outcomes:
measure: Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression
timeFrame: at baseline, monthly until month 4 then q2months until progression
measure: Phase 2: Safety and steady state drug levels evaluated monthly
timeFrame: Monthly
measure: Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue
timeFrame: Dec 2009
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Rochester
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Madison
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Richmond
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Herlev
country: Denmark
facility: Novartis Investigative Site
city: Saint-Herblain Cédex
country: France
facility: Novartis Investigative Site
city: Villejuif Cedex
country: France
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: