Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

Part of paid clinical trials in La Jolla, California.

Sponsor
Astellas Pharma Inc
Study ID
NCT01221077
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OSI-906 — DRUG
    As of 01 March 2013, OSI-906 is no longer being administered
  • Erlotinib — DRUG
    Erlotinib administered orally
  • Placebo — DRUG
    As of 01 March 2013, the matching placebo is no longer being administered

Study Details

A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who are Chemonaive.

Key Dates

First listed
Oct 14, 2010
Start date
Apr 8, 2011
Status verified
Nov 2025
Primary completion
Mar 1, 2013
Completion
Sep 1, 2014

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Erlotinib plus OSI-906
    As of 01 March 2013, OSI-906 is no longer being administered
  • Placebo Comparator: Arm B: Erlotinib plus Placebo
    As of 01 March 2013, the matching placebo is no longer being administered

Primary Outcome Measure

Progression-free survival of OSI-906 in combination with Erlotinib or Erlotinib plus placebo [ Time Frame: 15 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of California, San Diego/Moores Cancer CenterLa JollaCalifornia92093-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Cleveland Clinic FloridaWestonFlorida33331-
Northwestern Memorial HospitalChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
Karmanos Cancer InstituteDetroitMichigan48201-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Medical University of South CarolinaCharlestonSouth Carolina29425-
University of Tennessee Cancer InstituteMemphisTennessee31804-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Seattle Cancer Care Alliance University of WashingtonSeattleWashington98109-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in La Jolla, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of California, San Diego/Moores Cancer Center· La Jolla, CAH. Lee Moffitt Cancer Center and Research Institute· Tampa, FLCleveland Clinic Florida· Weston, FLNorthwestern Memorial Hospital· Chicago, ILRush University Medical Center· Chicago, ILJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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