Spots Global Cancer Trial Database for Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
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Trial Identification
Brief Title: Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Official Title: An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations
Study ID: NCT01953926
Study Description
Brief Summary: This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.
Detailed Description: This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. The study has a basket design and includes several cohorts, either defined by an actionable somatic mutation or by actionable mutation and tumor histology, including HER2 mutant breast, HER2 mutant cervical, HER2 mutant salivary gland, and EGFR Exon 18 mutant Non-small cell lung cancers. The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
City of Hope, Duarte, California, United States
University of California, San Diego, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
University of California, Los Angeles, Los Angeles, California, United States
Stanford Cancer Center, Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Kaiser Permanente NoCal (STRATA), Vallejo, California, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
UPMC Magee-Woman's Hospital, Women's Cancer Center, Pittsburgh, Pennsylvania, United States
Saint Francis Cancer Center-Bon Secours, Greenville, South Carolina, United States
The West Clinic, Germantown, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Gundersen Center for Cancer and Blood Disorders, La Crosse, Wisconsin, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
UZ Leuven, Leuven, , Belgium
British Columbia Cancer Center, Vancouver, British Columbia, Canada
University Hospital, Rigshospitalet, Kopenhagen, , Denmark
Institut Curie - Hopital Rene Huguenin, Saint-Cloud, Ile De France, France
Institut Gustave Roussy, Villejuif, Paris, France
Institut Bergonié, Bordeaux, , France
Centre Leon Berard, Lyon, , France
St. Vincent's University Hospital, Dublin, Leinster, Ireland
Hadassah Medical Center, Jerusalem, , Israel
Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Kaplan Medical Center, Rehovot, , Israel
Sourasky Medical Center, Tel Aviv, , Israel
Azienda Socio Sanitaria Territoriale di Cremona, Cremona, , Italy
Istituto Europeo di Oncologia (IEO) I.R.C.C.S., Milano, , Italy
Fondazione Policlinico Universitario Gemelli I.R.C.C.S., Roma, , Italy
AOU Citta della Salute e della Scienza di Torino, Torino, , Italy
Yonsei University Health System, Serverance Hospital, Seodaemun-Gu, Seoul, Korea, Republic of
Institute for Oncology and Radiology of Serbia, Belgrade, , Serbia
Hospital Universitario Quiron Dexeus, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitari Clinic Barcelona, Barcelona, , Spain
Hospital Clinico Universitario San Carlos, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario Madrid Sanchinarro (START Madrid), Madrid, , Spain
Hospital Universitario Quiron Madrid, Madrid, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Royal Free Hospital, London, , United Kingdom
Contact Details
Name: Chief Scientific Officer
Affiliation: Puma Biotechnology, Inc.
Role: STUDY_DIRECTOR
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