Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Bessemer, Alabama.

Sponsor
Eisai Inc.
Study ID
NCT01104155
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • eribulin mesylate + erlotinib — DRUG
    21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.
  • eribulin mesylate + erlotinib — DRUG
    28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.

Study Details

This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer.

Key Dates

First listed
Apr 15, 2010
Start date
Feb 22, 2010
Status verified
Jan 2018
Primary completion
Apr 7, 2011
Completion
Jan 18, 2017

Study Design

Enrollment
123 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: eribulin mesylate, 21 day cycle
  • Active Comparator: eribulin mesylate, 28 day cycle

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From date of first dose of study drug until, or up to the date of data cutoff (07 Apr 2011) ]

Locations (50)

FacilityCityStateZIPSite coordinators
-BessemerAlabama--
-BirminghamAlabama--
-Beverly HillsCalifornia--
-La JollaCalifornia--
-AuroraColorado--
-BoulderColorado--
-Colorado SpringsColorado--
-DenverColorado--
-LakewoodColorado--
-LittletonColorado--
-Lone TreeColorado--
-LongmontColorado--
-ParkerColorado--
-ThorntonColorado--
-Washington D.C.District of Columbia--
-OcalaFlorida--
-Port Saint LucieFlorida--
-Kansas CityKansas--
-Overland ParkKansas--
-Shawnee MissionKansas--
-DetroitMichigan--
-ColumbiaMissouri--
-Jefferson CityMissouri--
-Kansas CityMissouri--
-Lee's SummitMissouri--
-St LouisMissouri--
-Las VegasNevada--
-Elizabeth CityNorth Carolina--
-PortlandOregon--
-TualatinOregon--
-PhiladelphiaPennsylvania--
-East ProvidenceRhode Island--
-DallasTexas--
-Fort WorthTexas--
-GarlandTexas--
-PlanoTexas--
-ArlingtonVirginia--
-ChesapeakeVirginia--
-FairfaxVirginia--
-GainesvilleVirginia--
-HamptonVirginia--
-LeesburgVirginia--
-Newport NewsVirginia--
-NorfolkVirginia--
-Virginia BeachVirginia--
-WilliamsburgVirginia--
-WinchesterVirginia--
-WoodbridgeVirginia--
-SpokaneWashington--
-VancouverWashington--

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By condition
Lung cancer
By specialty
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