Phase 0 mesothelioma clinical trials are designed to determine if and how a new mesothelioma drug might work in a human. Mesothelioma patients are currently not eligible to enroll in phase 0 studies, but they may be in the near future.
Phase 0 studies for mesothelioma often use only a few small doses of the new drug in each patient. Researchers test whether the drug reaches the tumors, how the drug behaves in the body and how the cancer cells respond. Due to the very low doses of drug in phase 0 studies, there is low risk to mesothelioma patients compared to other phases. However, there’s likewise virtually no potential benefit to a patient enrolled in a phase 0 study. With the requirement of having extra biopsies, scans and blood samples taken, enrolling in a phase 0 study is not usually worth a patient’s time and effort.
Then why conduct phase 0 studies at all? Phase 0 studies help researchers determine whether drugs will do what they’re expected to do in a human body based on studies in the laboratory. Testing conservatively this way with phase 0 studies will usually bring any potential problems to light quickly. Phase 0 studies aren’t included in clinical trials for every drug and when they are used, they’re very small, usually with less than 20 subjects.
Mesothelioma Clinical Trials
The third and final part of this clinical trials overview blog series will focus on phases III and IV clinical trials.