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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456833
• Other study ID #: CRAD001C2111
• Secondary ID: 2004-003017-16
• Status: Completed
• Phase: Phase 1
• Start date: June 2005

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• RAD001

• erlotinib

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Richmond	British Columbia
Canada	Novartis Investigative Site	Toronto	Ontario
Denmark	Novartis Investigative Site	Herlev
France	Novartis Investigative Site	Saint-Herblain Cédex
France	Novartis Investigative Site	Villejuif Cedex
Russian Federation	Novartis Investigative Site	Moscow
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Madison	Wisconsin
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		first 28 days of combined treatment
Primary	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		at baseline and after 8 weeks of treatment
Secondary	Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression		at baseline, monthly until month 4 then q2months until progression
Secondary	Phase 2: Safety and steady state drug levels evaluated monthly		Monthly
Secondary	Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue		Dec 2009

External Links

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