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Brief Title: This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer.
Official Title: An Open Label, Phase Ib, Dose-escalation Study Evaluating the Safety and Tolerability of Xentuzumab and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumours and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive, HER2-, Breast Cancer, Followed by Expansion Cohorts.
Study ID: NCT03099174
Brief Summary: This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: * Xentuzumab in combination with abemaciclib * Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer. Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib. For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California Los Angeles, Santa Monica, California, United States
Yale University School of Medicine, New Haven, Connecticut, United States
University of Miami, Miami, Florida, United States
University of Minnesota, Minneapolis, Minnesota, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Herlev and Gentofte Hospital, Herlev, , Denmark
Copenhagen University Hospital, Rigshospitalet, København Ø, , Denmark
Docrates Clinic, Helsinki, , Finland
HUCH Comprehensive Cancer Center, building 2, Helsinki, , Finland
Tampere University Hospital, Tampere, , Finland
CRST - Clinical Research Services Turku, Turku, , Finland
HOP Jean Minjoz, Besançon, , France
INS Paoli-Calmettes, Marseille, , France
INS Curie, Paris, , France
Ctr Cario, Plerin Sur Mer, , France
Aichi Cancer Center Hospital, Aichi, Nagoya, , Japan
National Cancer Center Hospital East, Chiba, Kashiwa, , Japan
Tokai University Hospital, Kanagawa, Isehara, , Japan
National Cancer Center Hospital, Tokyo, Chuo-ku, , Japan
National Cancer Center, Goyang, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Clínica Universidad de Navarra - Madrid, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Fundación Jiménez Díaz, Madrid, , Spain
Hospital Virgen de la Victoria, Malaga, , Spain
Hospital Quirónsalud Madrid, Pozuelo de Alarcón, , Spain
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR