This study consists of Part 1 (in which AMG 193 is given alone) and Part 2 (in which AMG 193 is given in combination with docetaxel). 1Your doctor will inform you about which part of the study you are taking part in. AMG 193 is a tablet that is swallowed. Docetaxel is administered as an intravenous infusion.
Approximately 649 patients will participate in this study (ea. 28 of them in Switzerland). The total duration of study participation for each participant is expected to be 2 years.
Aim of the study
With this project, we wanted to investigate the efficacy (how well something works), tolerability (how the study drug makes you feel) and safety of the investigational drug AMG 193 alone and in combination with docetaxel when used to treat solid tumors with a very specific DNA mutation.
Who can take part?
Patients with advanced solid MTAP-null tumors.
Procedure
If you agree to participate in the study and pass the screening tests, you will receive AMG 193 as a study drug.
You will participate in the study as long as the investigator believes that you will benefit from the study treatment.
You must visit the investigator regularly. The visits will be more frequent at the beginning of your participation in the study, approx. 5 visits in the first cycle, approx. 2 in the second cycle and 1 visit from the third cycle onwards.
In addition to the main study, there are other research projects in which you can participate.
Compensation
Original study name
A phase 1/1b/2 study of AMG 193 alone and in combination with docetaxel in patients with advanced MTAP-null solid tumors
BASEC number
2021-02428
Sponsors