Spots Global Cancer Trial Database for Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer
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Trial Identification
Brief Title: Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer
Official Title: A Phase 1/2 Study Of HKI-272 In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer
Study ID: NCT00706030
Study Description
Brief Summary: The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group, Fayetteville, Arkansas, United States
City of Hope National Medical Center, Duarte, California, United States
Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Albert Einstein Cancer Center, Bronx, New York, United States
Columbia University Medical Center, New York, New York, United States
Hematology Oncology Associates of Rockland, Nyack, New York, United States
Carolinas Hematology-Oncology Associates, Charlotte, North Carolina, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
AZ Klina Brasschaat, Brasschaat, , Belgium
Institut Jules Bordet, Brussels, , Belgium
St.-Augustinus Hospital Oncology Department, Wilrijk, , Belgium
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army, Beijing, Beijing, China
Chinese People's Liberation Army General Hospital, Beijing, Beijing, China
Tianjin Cancer Hospital, TianJin, Tianjin, China
Centre Paul Papin, Angers, , France
Institut Paoli Calmette, Marseille, , France
Institut Curie, Département d'Oncologie Médicale, Paris, , France
Institut Claudius Regaud, Toulouse, , France
Queen Mary Hospital, Hong Kong, , Hong Kong
UNIMED Medical Institute, Hong Kong, , Hong Kong
Martini Ziekenhuis / Afdeling Interne Geneeskunde, Groningen, , Netherlands
Centrum Onkologii Ziemii Lubelskiej, Oddział Chemioterapii, Lublin, , Poland
Wojskowy Instytut Medyczny, Klinika Onkologii, Warszawa, , Poland
Centro Oncologico de Galicia, A Coruña, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Arnau de Vilanova, Servicio de Oncologia Medica, Lleida, , Spain
Hospital 12 de Octubre, Servicio de Oncologia Medica, Madrid, , Spain
Onkologiska Kliniken Universitetssjukhuset i Lund, Lund, , Sweden
National Taiwan University Hospital, Taipei, , Taiwan
Broomfield Hospital, Chelmsford, Essex, United Kingdom
Southampton General Hospital, Southampton, Hampshire, United Kingdom
Christie NHS Foundation Trust, Manchester, Lancashire, United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
Guy's and St. Thomas' NHS Foundation Trust, Guy's Hospital, London, , United Kingdom
Contact Details
Name: Puma
Affiliation: Biotechnology
Role: STUDY_DIRECTOR
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