A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Eisai Inc.
Study ID
NCT01454934
Phase
PHASE3
Status
Completed

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Eribulin — DRUG
    Administration of eribulin mesylate at a dose of 1.4 mg/m2 i.v. over 2 to 5 minutes on Days 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
  • TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed — DRUG
    * Vinorelbine 30 mg/m2 i.v. on Day 1, every 7 days * Gemcitabine 1250 mg/m2 i.v. on Days 1 and 8, every 21 days * Docetaxel 75 mg/m2 i.v. on Day 1 every 21 days * Pemetrexed 500 mg/m2 i.v. on Day 1 every 21 days (nonsquamous histology only).

Study Details

This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

Key Dates

Start date
Dec 9, 2011
Status verified
Aug 2017
Primary completion
May 30, 2014
Completion
May 2, 2016

Study Design

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

Arms

  • Experimental: Arm A
  • Active Comparator: Arm B

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Randomization (Day 1) until date of death from any cause, or 37 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
-Los AngelesCalifornia--
-Pleasant HillCalifornia--
-San DiegoCalifornia--
-AuroraColorado--
-Washington D.C.District of Columbia--
-Port Saint LucieFlorida--
-DecaturIllinois--
-SouthfieldMichigan--
-LebanonNew Hampshire--
-Lake SuccessNew York--
-PortlandOregon--
-SpokaneWashington--
-MadisonWisconsin--

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