My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT02091141
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Trastuzumab — DRUG
    Trastuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
  • Pertuzumab — DRUG
    Pertuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
  • Erlotinib — DRUG
    Erlotinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
  • Vemurafenib — DRUG
    Vemurafenib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
  • Cobimetinib — DRUG
    Cobimetinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
  • Vismodegib — DRUG
    Vismodegib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
  • Alectinib — DRUG
    Alectinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
  • Atezolizumab — DRUG
    Atezolizumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.

Study Details

This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.

Key Dates

Start date
Apr 14, 2014
Status verified
Jun 2024
Primary completion
May 24, 2023
Completion
May 24, 2023

Study Design

Enrollment
673 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab Plus Pertuzumab
    Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
  • Experimental: Atezolizumab
    Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
  • Experimental: Vemurafenib
    Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
  • Experimental: Vemurafenib Plus Cobimetinib
    Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
  • Experimental: Vismodegib
    Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
  • Experimental: Alectinib
    Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
  • Experimental: Erlotinib
    Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.

Primary Outcome Measure

Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator [ Time Frame: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months) ]

Locations (60)

FacilityCityStateZIPSite coordinators
Western Regional Medical Center at Cancer Treatment Centers of AmericaGoodyearArizona85338-
Mayo Clinic ArizonaPhoenixArizona85259-
Highlands Oncology GroupSpringdaleArkansas72762-
Science 37, IncCulver CityCalifornia90230-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Moores UCSD Cancer Center; Dept Clinical Trials OfficeLa JollaCalifornia92093-0698-
Eisenhower Medical CenterRancho MirageCalifornia92270-
Stanford Comprehensive Cancer CenterStanfordCalifornia94305-
Kaiser Permanente - VallejoVallejoCalifornia94589-
University of ColoradoAuroraColorado80045-2517-
SCRI Florida Cancer Specialists SouthFort MyersFlorida33916-
Mayo ClinicJacksonvilleFlorida32224-
Florida Hospital Cancer Inst; Memorial System Onc Clin RschOrlandoFlorida32804-
Florida Cancer Specialist, North RegionSt. PetersburgFlorida33705-
Florida Cancer Specialists, Research DepartmentWest Palm BeachFlorida33401-
University Cancer & Blood Center, LLC; ResearchAthensGeorgia30607-
Northeast Georgia Medical Center; Oncology Research Dept-5CGainesvilleGeorgia30501-
Southeastern Regional Medical Center, Inc.NewnanGeorgia30265-
Northwestern University; Robert H. Lurie Comp Can Ctr; Northwestern Medicine Development InstChicagoIllinois60611-
University Of Chicago Medical Center; Section Of Hematology/OncologyChicagoIllinois60637-
Midwestern Regional Med CenterZionIllinois60099-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287-
Mayo FoundationRochesterMinnesota55905-
Research Medical Center - Antibiotic Research Associates, Inc.Kansas CityMissouri64132-
Memorial Sloan Kettering - MonmouthMiddletownNew Jersey07748-
University of New MexicoAlbuquerqueNew Mexico87131-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87102-
University of New Mexico Comprehensive Cancer Center - Albuquerque Cedar Street; Drug ShipmentAlbuquerqueNew Mexico87106-
University of New Mexico Comprehensive Cancer Center - Albuquerque Lang NE; Drug ShipmentAlbuquerqueNew Mexico87109-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
Memorial Sloan Kettering Cancer Center at WestchesterHarrisonNew York10604-
Herbert Irving Comprehensive Cancer Center; Herbert Irving PavillionNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Weill Cornell Univ Medical Ctr; Breast Cancer CenterNew YorkNew York10021-
Univ No Carolina School of Med; Physicians Office BldgChapel HillNorth Carolina27599-7305v-
Duke University Medical CenterDurhamNorth Carolina27710-
Wake Forest Univ Health Svcs; Internal MedicineWinston-SalemNorth Carolina27157-
Sanford Roger Maris Cancer CenterFargoNorth Dakota58102-
Oncology Hematology Care IncCincinnatiOhio45242-
Cleveland ClinicClevelandOhio44106-
University Hospitals of ClevelandClevelandOhio44106-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Providence Portland Medical CenterPortlandOregon97213-
Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Eastern Regional Medical CtrPhiladelphiaPennsylvania19124-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
UPMC - Hillman Cancer CenterPittsburghPennsylvania15232-
Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc InsWillow GrovePennsylvania19090-
Sanford Cancer Cnt Onco ClinicSioux FallsSouth Dakota57104-
Sarah Cannon Research Institute / Tennessee OncologyChattanoogaTennessee37404-
West ClinicGermantownTennessee38138-
Tennessee Cancer SpecialistsKnoxvilleTennessee37920-
Tennessee Oncology - NashvilleNashvilleTennessee37203-
Vanderbilt Ingram Cancer ClinicNashvilleTennessee37232-
The Center for Cancer and Blood Disorders - Fort WorthFort WorthTexas76104-
MD AndersonHoustonTexas77030-
Virginia Cancer InstituteRichmondVirginia23229-
Northwest Medical SpecialtiesTacomaWashington98405-
University of WisconsinMadisonWisconsin53705-
Medical College of WisconsinMilwaukeeWisconsin53226-

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