TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Clovis Oncology, Inc.
Study ID
NCT02186301
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Rociletinib Mono-Therapy — DRUG
    Rociletinib will be administered twice daily
  • Erlotinib Mono-Therapy — DRUG
    Erlotinib will be administered once a day

Study Details

The purpose of this study is to compare the safety and anti-tumor effect of rociletinib with erlotinib in patients whose tumors have specific EGFR mutations and who have not previously received any treatment for advanced/metastatic EGFR mutated NSCLC. This study is a 'Randomized' Study. This means that upon entering the study, patients will be randomly assigned to be dosed with either rociletinib twice a day or erlotinib once a day. Patients will continue to take either rociletinib or erlotinib until it is no longer beneficial.

Key Dates

Start date
Nov 30, 2014
Status verified
Apr 2019
Primary completion
Jun 28, 2017
Completion
Jun 28, 2017

Study Design

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

Arms

  • Active Comparator: Erlotinib Mono-Therapy
  • Experimental: Rociletinib Mono-Therapy

Primary Outcome Measure

Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS) [ Time Frame: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months ]

Locations (54)

FacilityCityStateZIP
University of Alabama at BirminghamBirminghamAlabama35294
East Valley Hematology and Oncology Medical Group, Inc.BurbankCalifornia91505
City of HopeDuarteCalifornia91010
Compassionate Cancer Care Medical Group, Inc.Fountain ValleyCalifornia92708
St. Joseph Heritage HealthcareFullertonCalifornia92835-3825
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-0698
University of Southern California, Norris Comprehensive Cancer CenterLos AngelesCalifornia90089
Sutter Medical GroupSacramentoCalifornia95816
University of California San FranciscoSan FranciscoCalifornia94115
Sansum ClinicSanta BarbaraCalifornia93105
Central Coast Medical Oncology CorporationSanta MariaCalifornia93454
UCLA Medical CenterSanta MonicaCalifornia90404
The Oncology Institute of Hope and InnovationWhittierCalifornia90603
University of Colorado Cancer CenterAuroraColorado80045
Georgetown University Medical CenterWashington D.C.District of Columbia20007
Cancer Specialists of North FloridaFleming IslandFlorida32003
Florida Cancer Specialists and Research InstituteFort MyersFlorida33916
Advanced Medical SpecialtiesMiamiFlorida33176
Florida Hospital Cancer InstituteOrlandoFlorida32804
Florida Cancer SpecialistsSt. PetersburgFlorida33705
Cleveland Clinic FloridaWestonFlorida33331
Northwestern UniversityChicagoIllinois60611
University of Illinois Cancer CenterChicagoIllinois60612
Illinois Cancer SpecialistsNilesIllinois60714
Harry and Jeanette Weinberg Cancer Institute at Franklin SquareBaltimoreMaryland21237
Walter Reed Army Institute of ResearchBethesdaMaryland20889
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201
Oncology Hematology West PCOmahaNebraska68130
Comprehensive Cancer Centers of NevadaHendersonNevada89014
Regional Cancer Care Associates, LLCEast BrunswickNew Jersey08816
Regional Cancer Care AssociatesMorristownNew Jersey07962
Roswell Park Cancer InstituteBuffaloNew York14263
Montefiore Medical CenterThe BronxNew York10461
Duke University Medical CenterDurhamNorth Carolina27710
University of Cincinnati Medical CenterCincinnatiOhio45267
Cleveland ClinicClevelandOhio44195
University Hospitals Case Medical CenterClevelandOhio44106
Oregon Health and Science UniversityPortlandOregon97239
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Hollings Cancer CenterCharlestonSouth Carolina29425
Tennessee Oncology, PLLCChattanoogaTennessee37404
Tennessee Oncology, PLLCNashvilleTennessee37203
USC/Norris Comprehensive Cancer CenterNashvilleTennessee37212-3505
Texas Oncology, PAAustinTexas78745
Texas Oncology-BeaumontBeaumontTexas77702
Texas Oncology, P.A.BedfordTexas76022
University of Texas Southwestern Medical CenterDallasTexas75390-8852
Houston Methodist Cancer CenterHoustonTexas77030
The University of Texas - MD Anderson Cancer CenterHoustonTexas77030
Texas Oncology-Plano EastPlanoTexas75075-7753
Virginia Cancer Specialists, PCFairfaxVirginia22031
University of WashingtonSeattleWashington98109
Northwest Cancer Specialists, P.C.VancouverWashington98684
Yakima Valley Memorial Hospital, North Star LodgeYakimaWashington98902

Find similar trials in Birmingham, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Alabama at Birmingham· Birmingham, ALEast Valley Hematology and Oncology Medical Group, Inc.· Burbank, CACity of Hope· Duarte, CACompassionate Cancer Care Medical Group, Inc.· Fountain Valley, CASt. Joseph Heritage Healthcare· Fullerton, CAUC San Diego Moores Cancer Center· La Jolla, CA

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