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
- Conditions
- NeoplasmsBreast Neoplasms
- Interventions
- Registration Number
- NCT03099174
- Lead Sponsor
- Boehringer Ingelheim
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A Xentuzumab Xentuzumab + Abemaciclib (Dose 1) Cohort A Abemaciclib Xentuzumab + Abemaciclib (Dose 1) Cohort F Abemaciclib Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort B Xentuzumab Xentuzumab + Abemaciclib + Letrozole (Dose 2) Cohort B Abemaciclib Xentuzumab + Abemaciclib + Letrozole (Dose 2) Cohort B Letrozole Xentuzumab + Abemaciclib + Letrozole (Dose 2) Cohort D1 Xentuzumab Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort C Xentuzumab Xentuzumab + Abemaciclib + Anastrozole (Dose 3) Cohort C Abemaciclib Xentuzumab + Abemaciclib + Anastrozole (Dose 3) Cohort C Anastrozole Xentuzumab + Abemaciclib + Anastrozole (Dose 3) Cohort D Xentuzumab Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort D1 Abemaciclib Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort D2 Xentuzumab Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort D2 Abemaciclib Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort D Abemaciclib Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort D Fulvestrant Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort F Fulvestrant Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort E Abemaciclib Xentuzumab + Abemaciclib (Dose 1) Cohort D1 Fulvestrant Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort D2 Fulvestrant Xentuzumab + Abemaciclib + Fulvestrant (Dose 4) Cohort E Xentuzumab Xentuzumab + Abemaciclib (Dose 1) Cohort F Xentuzumab Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)
- Primary Outcome Measures
Name Time Method Cohorts A, B,C & D - Maximum Tolerated Dose (MTD) 28 days Cohorts D1 & D2 - Progression-free survival (PFS) rate 18 Months Cohort F: disease control (DC) defined as best overall response of complete response (CR) or partial response (PR) or confirmed stable disease (SD) or Non-CR/ Non-PD where best overall response is defined according to RECIST version 1.1 24 weeks Cohorts A, B,C & D - Number of patients with dose limiting toxicities (DLT) in the Maximum Tolerated Dose (MTD) evaluation period 28 days Cohorts E: objective response (OR), defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. 12 months
- Secondary Outcome Measures
Name Time Method Cohorts E, D1 & D2: Disease control (DC) defined as best overall response of complete response (CR) or partial response (PR) or confirmed stable disease (SD) where best overall response is defined according to RECIST version 1.1 12 months Cohorts E, F, D1 & D2: Time to objective response defined as the time from first treatment administration until first documented complete response (CR) or partial response (PR). up to 12 months Cohorts E, D1 & D2: Duration of objective response defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression or death among patients with objective response up to 12 months Cohorts E, F, D1 & D2: Duration of disease control is defined as the time from first treatment administration until the earliest of disease progression or death, among patients with disease control 12 months Cohorts E, F, D1 & D2: Progression-free survival (PFS) 12 months Cohorts D1 & D2: Objective response (OR) defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 12 months
Trial Locations
- Locations (30)
University of California Los Angeles
🇺🇸Santa Monica, California, United States
University of Miami
🇺🇸Miami, Florida, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Hospital Quirónsalud Madrid
🇪🇸Pozuelo de Alarcón, Spain
National Cancer Center
🇰🇷Goyang, Korea, Republic of
Clínica Universidad de Navarra - Madrid
🇪🇸Madrid, Spain
INS Paoli-Calmettes
🇫🇷Marseille, France
Yale University School of Medicine
🇺🇸New Haven, Connecticut, 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
Docrates Clinic
🇫🇮Helsinki, Finland
Copenhagen University Hospital, Rigshospitalet
🇩🇰København Ø, Denmark
HUCH Comprehensive Cancer Center, building 2
🇫🇮Helsinki, Finland
CRST - Clinical Research Services Turku
🇫🇮Turku, Finland
HOP Jean Minjoz
🇫🇷Besançon, France
INS Curie
🇫🇷Paris, France
National Cancer Center Hospital East
🇯🇵Chiba, Kashiwa, Japan
Ctr Cario
🇫🇷Plerin Sur Mer, France
Tokai University Hospital
🇯🇵Kanagawa, Isehara, Japan
Aichi Cancer Center Hospital
🇯🇵Aichi, Nagoya, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Tampere University Hospital
🇫🇮Tampere, Finland