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

First listed
Jul 10, 2014
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)

FacilityCityStateZIPSite coordinators
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-

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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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