NCT00456833

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for phase_1

Geographic Reach
5 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Last Updated

December 21, 2020

Status Verified

April 1, 2012

Enrollment Period

5.8 years

First QC Date

April 4, 2007

Last Update Submit

December 17, 2020

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung CancerNSCLCAdvanced lung cancerRADRAD001erlotinib

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

RAD 5mg/day + erlotinib

EXPERIMENTAL
Drug: RAD001

erlotinib 150mg/day

ACTIVE COMPARATOR
Drug: RAD001Drug: erlotinib

Interventions

RAD001DRUG
RAD 5mg/day + erlotiniberlotinib 150mg/day
erlotinibDRUG
erlotinib 150mg/day

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Novartis Investigative Site

Atlanta, Georgia, 30322, United States

Location

Novartis Investigative Site

Chicago, Illinois, 60637-1470, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02115, United States

Location

Novartis Investigative Site

Rochester, Minnesota, 55905, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37203, United States

Location

Novartis Investigative Site

Houston, Texas, 77030-4009, United States

Location

Novartis Investigative Site

Madison, Wisconsin, 53792, United States

Location

Novartis Investigative Site

Richmond, British Columbia, V7C 5L9, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H2L 4M1, Canada

Location

Novartis Investigative Site

Herlev, DK-2730, Denmark

Location

Novartis Investigative Site

Saint-Herblain Cédex, 44805, France

Location

Novartis Investigative Site

Villejuif, 94805, France

Location

Novartis Investigative Site

Moscow, 115478, Russia

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

EverolimusErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

June 1, 2005

Primary Completion

March 1, 2011

Last Updated

December 21, 2020

Record last verified: 2012-04

Locations

DK(1)CA(3)US(7)FR(2)RU(1)