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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT00456833
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 5, 2007
Start date
Jun 30, 2005
Status verified
Apr 2012
Primary completion
Mar 31, 2011

Study Design

Enrollment
248 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RAD 5mg/day + erlotinib
  • Active Comparator: erlotinib 150mg/day

Primary 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. [ Time Frame: first 28 days of combined treatment ]

Locations (7)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteAtlantaGeorgia30322-
Novartis Investigative SiteChicagoIllinois60637-1470-
Novartis Investigative SiteBostonMassachusetts02115-
Novartis Investigative SiteRochesterMinnesota55905-
Novartis Investigative SiteNashvilleTennessee37203-
Novartis Investigative SiteHoustonTexas77030-4009-
Novartis Investigative SiteMadisonWisconsin53792-

Find similar trials in Atlanta, GA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Novartis Investigative Site· Atlanta, GANovartis Investigative Site· Chicago, ILNovartis Investigative Site· Boston, MANovartis Investigative Site· Rochester, MNNovartis Investigative Site· Nashville, TNNovartis Investigative Site· Houston, TX

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