Safety, Tolerability and Anti-tumour Activity Study of MTL-CEBPA Plus Sorafenib

Summary

Participation Requirements

Description

After a participant has signed the consent form (to confirm they wish to participate in the study) a number of assessments (screening) will be completed to determine whether they are suitable to be enrolled in the study. The first dose of experimental drug (MTL-CEBPA) will be given via infusion on t...

After a participant has signed the consent form (to confirm they wish to participate in the study) a number of assessments (screening) will be completed to determine whether they are suitable to be enrolled in the study. The first dose of experimental drug (MTL-CEBPA) will be given via infusion on the first day (Day 1) of the study. It will subsequently be administered to participants once a week for the first 3 weeks in each cycle (the fourth week is a rest week? each cycle consists of 4 weeks). Sorafenib (a drug which is already used to treat liver cancer) will be started on the eighth day of the study (tablets) and taken daily whilst the participant is in the study. If the participant is tolerating the combination of drugs and there is no evidence that the cancer is advancing they will continue to receive cycles (28 days in length) of treatment (being administered both MTL-CEBPA and sorafenib). All participants will have contrast-enhanced CT scans (form of X-ray) of the chest, abdomen and pelvis at the beginning of the study and then every 8 weeks whilst in the study. Assessments will be completed throughout the study to ensure the combination of drugs is safe. These will include recording any adverse events (untoward medical occurrences), vital signs (such as blood pressure, pulse, body temperature, and breathing rates), ECG, and completing blood tests. Blood samples, analysed in both local (hospital) and central laboratories (ie, facilities independent of hospital labs)will be taken throughout the study but less frequently from Cycle 2 onwards. The maximum amount of blood taken in any 28-day treatment cycle is approximately 150 mL. A patient questionnaire will be used to assess changes in health-related quality of life for participants. The questionnaire will be used for all participants in the study and will be completed every 3 weeks. All participants must agree to undergo a liver tumour biopsy prior to being administered with the study treatment. A post treatment biopsy of the tumour area one day after the last MTL-CEBPA administration of week 3 (Cycle 2) is mandated for all participants.

Tracking Information