This study is no longer open to new participants. It was a study in adults with advanced cancer in the stomach and oesophagus. This is a study for people for whom previous treatment was not successful or no treatment exists. In this study, BI 3706674 is given to humans for the first time. The purpose of this study is to find a suitable dose of BI 3706674 that people with advanced cancer can tolerate when taken alone. Another purpose is to check whether BI 3706674 can make tumours shrink. BI 3706674 blocks growth signals and may prevent the tumour from growing. Participants take BI 3706674 as a tablet when starting treatment. Different doses of BI 3706674 are tested during this study. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
BI 3706674
Mayo Clinic-Arizona
Phoenix, Arizona, United States
Yale Cancer Center
New Haven, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
National Cancer Center Hospital East
Chiba, Kashiwa, Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
...and 7 more locations
Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time frame: up to 28 days
Part B: Occurrence of drug-related adverse events (AEs) ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 during the on-treatment period
Time frame: up to 3.5 years
Part C: Objective response (OR) based on central assessment
OR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent.
Time frame: up to 3.5 years
Part A: Occurrence of DLTs during the on-treatment period
Time frame: up to 3.5 years
Part B: Occurrence of DLTs during the on-treatment period
Time frame: up to 3.5 years
Part B: OR based on central assessment
OR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent.
Time frame: up to 3.5 years
Part B: Duration of objective response (DOR)
DOR is defined as the time from first documented CR or PR until the earliest of disease progression or death among patients with objective response.
Time frame: up to 3.5 years
Part B: Tumour shrinkage
Tumour shrinkage is defined as the difference between the minimum post-baseline sum of diameters of target lesions (long axis for non-nodal lesions, short axis for nodal lesions) and the baseline sum of diameters of the same set of target lesions.
Time frame: up to 3.5 years
Part B: Progression-free survival (PFS)
PFS is defined as the time from first treatment administration until tumour progression according to RECIST version 1.1 or death from any cause, whichever occurs earlier.
Time frame: up to 3.5 years
Part C: Duration of objective response
Time frame: up to 3.5 years
Part C: Tumour shrinkage
Time frame: up to 3.5 years
Part C: Progression-free survival (PFS)
Time frame: up to 3.5 years
All trial parts: Maximum measured concentration (Cmax) of BI 3706674 evaluated after the first dose in Cycle 1
Time frame: up to 28 days
All trial parts: Area under the plasma concentration-time curve over a uniform dosing interval τ (AUCτ) of BI 3706674 evaluated after the first dose in Cycle 1
Time frame: up to 28 days
Maximum measured concentration of BI 3706674 evaluated at steady state on Cycle 2 Day 1 (Cmax,ss)
Time frame: From Day 1 of Cycle 2 (each cycle is 28 days) up to 3.5 years
All trial parts: Area under the plasma concentration-time curve over a uniform dosing interval τ of BI 3706674 evaluated at steady state on Cycle 2 Day 1 (AUCτ,ss)
Time frame: From Day 1 of Cycle 2 (each cycle is 28 days) up to 3.5 years
All trial parts: Occurrence of AEs during the on-treatment period
Time frame: up to 3.5 years
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