This study is looking at a type of cancer called gastrointestinal stromal tumors, which are growths that occur in the digestive system. The study involves patients whose cancer has spread to other parts of the body or cannot be removed by surgery, and who have already received treatment with a medicine called imatinib but their disease has gotten worse or they could not tolerate that treatment. The study will compare two different medicines: GSK6042981, which is an experimental drug given as a tablet, and sunitinib malate, which is given as a capsule. Both medicines work as tyrosine kinase inhibitors, which are drugs that block certain proteins that help cancer cells grow.
The purpose of the study is to see if GSK6042981 works better than sunitinib malate in slowing down the growth of the cancer or stopping it from getting worse. Patients taking part in this study will be randomly assigned to receive either GSK6042981 or sunitinib malate, and both groups will know which medicine they are receiving. During the study, doctors will monitor how well the treatment is working and how long patients can go without their disease getting worse. Patients will also be asked about their quality of life and any side effects they may experience.
Throughout the study, doctors will collect tissue samples from tumors for laboratory testing, which may come from previously stored tissue or from a new biopsy. The study will also measure the levels of GSK6042981 in the blood and track various aspects of patient health, including how long patients live, how quickly the tumor responds to treatment, and whether the cancer gets worse after starting a different treatment following the study medicine. Patients will complete questionnaires about their symptoms and overall well-being to help researchers understand how the treatments affect daily life.
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