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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00456833

Collaborator

(none)

248

Enrollment

Locations

Arms

17.7

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: RAD001 Drug: erlotinib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

248 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RAD 5mg/day + erlotinib	Drug: RAD001
Active Comparator: erlotinib 150mg/day	Drug: RAD001 Drug: erlotinib

Arm

Intervention/Treatment

Experimental: RAD 5mg/day + erlotinib

Drug: RAD001

Active Comparator: erlotinib 150mg/day

Drug: RAD001

Drug: erlotinib

Outcome Measures

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. [first 28 days of combined treatment]
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 Outcome Measures

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]
Phase 2: Safety and steady state drug levels evaluated monthly [Monthly]
Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue [Dec 2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Atlanta	Georgia	United States	30322
2	Novartis Investigative Site	Chicago	Illinois	United States	60637-1470
3	Novartis Investigative Site	Boston	Massachusetts	United States	02115
4	Novartis Investigative Site	Rochester	Minnesota	United States	55905
5	Novartis Investigative Site	Nashville	Tennessee	United States	37203
6	Novartis Investigative Site	Houston	Texas	United States	77030-4009
7	Novartis Investigative Site	Madison	Wisconsin	United States	53792
8	Novartis Investigative Site	Richmond	British Columbia	Canada	V7C 5L9
9	Novartis Investigative Site	Toronto	Ontario	Canada	M5G 2M9
10	Novartis Investigative Site	Montreal	Quebec	Canada	H2L 4M1
11	Novartis Investigative Site	Herlev		Denmark	DK-2730
12	Novartis Investigative Site	Saint-Herblain Cédex		France	44805
13	Novartis Investigative Site	Villejuif Cedex		France	94805
14	Novartis Investigative Site	Moscow		Russian Federation	115478