A Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)

Study Description

This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).

Study Details

Registry ID:

NCT03318939

Conditions:

NSCLC

Phase:

Phase 2

Target Enrollment:

648 participants

Start Date:

October 11, 2017

Healthy Volunteers:

No

Study Locations (73 sites)

• University Hospital 12 de Octubre
  MadridSpain, Spain
• University Hospital Germans Trias i Pujol, Department of Medical Oncology
  Barcelona, BarcelonaSpain, Spain
• University Hospital Germans Trias i Pujol, Department of Medical Oncology
  BarcelonaSpain, Spain
• Hopital Larrey, CHU Toulouse, Unité d'Oncologie des Voies Respiratoires
  ToulouseFrance, France
• National Cancer Institute Regina Elena, IRCCS, Operative Unit of Medical Oncology A 1
  RomeItaly, Italy
• Santa Maria delle Croci Hospital
  RavennaItaly, Italy
• Santa Maria delle Croci Hospital
  Ravenna, Ravenna (ra)Italy, Italy
• National Cancer Institute, IRCCS, Department of Medical Oncology
  MilanItaly, Italy
• Soroka Medical Center
  Be'er ShevaIsrael, Israel
• Soroka Medical Center
  Be'er ShevaIsrael, Israel
• Rabin Medical Center
  Petah TikvaIsrael, Israel
• Hadassah Medical Center
  JerusalemIsrael, Israel
• Rambam Healthcare Campus
  HaifaIsrael, Israel
• Gustave Roussy Oncology Institute, Department of Medical Oncology
  VillejuifFrance, France
• Ambroise Pare University Hospital Center
  MonsBelgium, Belgium
• Ambroise Pare University Hospital Center
  Mons, HainautBelgium, Belgium
• Saint Luc University Hospital
  BrusselsBelgium, Belgium
• General Hospital Delta
  Roeselare, West FlandersBelgium, Belgium
• General Hospital Delta
  RoeselareBelgium, Belgium
• University Hospitals Leuven
  Leuven, Flemish BrabantBelgium, Belgium
• University Hospitals Leuven
  LeuvenBelgium, Belgium
• Erasmus Medical Center
  RotterdamNetherlands, Netherlands
• Erasmus Medical Center
  Rotterdam, South HollandNetherlands, Netherlands
• Massachusetts General Hospital
  Boston, MassachusettsUnited States, United States
• North Shore Hematology Oncology Associates P.C. DBA NY Cancer and Blood Specialists
  Port Jefferson Station, New YorkUnited States, United States
• Yale University, Yale Cancer Center Smilow Cancer Hospital at Yale
  New Haven, ConnecticutUnited States, United States
• North Shore Hematology Oncology Associates DBA New York Cancer and Blood Specialists
  The Bronx, New YorkUnited States, United States
• Montefiore Einstein Medical Center for Cancer Care
  The Bronx, New YorkUnited States, United States
• North Shore Hematology Oncology Associates DBA New York Cancer and Blood Specialists
  Bronx, New YorkUnited States, United States
• Montefiore Einstein Medical Center for Cancer Care
  Bronx, New YorkUnited States, United States
• NYU Langone Medical Center
  New York, New YorkUnited States, United States
• Weill Cornell Medical College
  New York, New YorkUnited States, United States
• CTCA - Eastern Regional Medical Center
  Philadelphia, PennsylvaniaUnited States, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  Baltimore, MarylandUnited States, United States
• Florida Hospital
  Orlando, FloridaUnited States, United States
• Georgetown University Medical Center
  Washington D.C., District of ColumbiaUnited States, United States
• Georgetown University Medical Center
  Washington, District of ColumbiaUnited States, United States
• The Bond & Steele Clinic, P.A. dba Bond Clinic, P.A.
  Winter Haven, FloridaUnited States, United States
• Virginia Cancer Specialists, PC
  Fairfax, VirginiaUnited States, United States
• Duke University Medical Center
  Durham, North CarolinaUnited States, United States
• H. Lee Moffitt Cancer Center & Research Institute
  Tampa, FloridaUnited States, United States
• Roswell Park Cancer Institute
  Buffalo, New YorkUnited States, United States
• University Cancer & Blood Center, LLC
  Athens, GeorgiaUnited States, United States
• Princess Margaret Cancer Centre
  Toronto, OntarioCanada, Canada
• CTCA - Southeastern Regional Medical Center
  Newnan, GeorgiaUnited States, United States
• Cleveland Clinic
  Cleveland, OhioUnited States, United States
• London Regional Cancer Program
  London, OntarioCanada, Canada
• The Ohio State University
  Columbus, OhioUnited States, United States
• Karmanos Cancer Institute
  Detroit, MichiganUnited States, United States
• Hattiesburg Clinic Hematology/Oncology
  Hattiesburg, MississippiUnited States, United States
• Baptist Cancer Center
  Memphis, TennesseeUnited States, United States
• CTCA - Midwestern Regional Medical Center
  Zion, IllinoisUnited States, United States
• MD Anderson Cancer Center
  Houston, TexasUnited States, United States
• Texas Oncology- Austin
  Austin, TexasUnited States, United States
• Mayo Clinic
  Rochester, MinnesotaUnited States, United States
• Oklahoma Cancer Specialists and Research Institute, LLC
  Tulsa, OklahomaUnited States, United States
• Minnesota Oncology Hematology, P.A.
  Minneapolis, MinnesotaUnited States, United States
• Rocky Mountain Cancer Center
  Boulder, ColoradoUnited States, United States
• Mayo Clinic Hospital
  Phoenix, ArizonaUnited States, United States
• UCSD -Moores Cancer Center
  La Jolla, CaliforniaUnited States, United States
• City of Hope
  Duarte, CaliforniaUnited States, United States
• Oncology Physician's Network Inc./OPN Healthcare
  Arcadia, CaliforniaUnited States, United States
• Pacific Shores Medical Group
  Long Beach, CaliforniaUnited States, United States
• Los Angeles Hematology Oncology Medical Group
  Los Angeles, CaliforniaUnited States, United States
• USC/Norris Comprehensive Cancer Center
  Los Angeles, CaliforniaUnited States, United States
• The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  Torrance, CaliforniaUnited States, United States
• UCLA Hematology/Oncology
  Santa Monica, CaliforniaUnited States, United States
• Cross Cancer Institute
  Edmonton, AlbertaCanada, Canada
• UC Davis Comprehensive Cancer Center
  Sacramento, CaliforniaUnited States, United States
• Kaiser Permanente Medical Center
  Vallejo, CaliforniaUnited States, United States
• UCSF Helen Diller Comprehensive Cancer Center at Mt Zion
  San Francisco, CaliforniaUnited States, United States
• Seattle Cancer Care Alliance
  Seattle, WashingtonUnited States, United States
• BC Cancer - Vancouver
  Vancouver, British ColumbiaCanada, Canada

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