A Phase I Trial of AZD3965 in Patients With Advanced Cancer
Status:
Completed
Trial end date:
2020-11-17
Target enrollment:
Participant gender:
Summary
The main aims of this clinical study are to find out the maximum dose that can be given
safely to patients, the potential side effects of the drug and how they can be managed and
what happens to AZD3965 inside the body.
AZD3965 is a type of drug called a monocarboxylate transporter 1 inhibitor which is being
used to stop the growth of cancer cells and kill cancer cells by blocking the action of one
of the proteins involved in moving chemical compounds in and out of the cells of the body.
This will be the first time that this type of drug has been given to patients.
The drug is a capsule and is taken daily. The study is in two parts. In Part 1 of the study,
small groups of patients were treated at increasing doses to find the highest safe dose and
best dose to give to patients in Part 2 of the study. 43 patients with advanced solid tumours
were treated in Part 1.
In Part 2, the dose found to be safe in Part 1 is given to patients with diffuse large B cell
lymphoma and Burkitt's Lymphoma. 15 - 20 patients will be treated in Part 2.
Patients will need to visit the hospital weekly for two months and then every fortnight.
Patients will have regular blood and urine tests, scans, heart traces and eye tests amongst
other clinical tests. Research blood samples will also be taken to look at what happens to
the drug inside the body. Treatment will continue until a patient's cancer starts growing but
can continue for up to a maximum of 12 months if the cancer is responding to the drug. It is
important to explain that this is the first study of this drug and patients will have
advanced cancer so it is unlikely that patients will benefit directly from taking part but
the study may help improve future treatment of cancer.