PCL102H1 Lecture Notes - Lecture 20: Vemurafenib, Xenotransplantation, Melanoma
27 Apr 2016
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Same gene is mutated in over half of melanomas. Initially phase 1 trial, later phase 2 and 3 as well. When saw that patients were not absorbing drug, wanted to test drug at more potent dose before giving to patients in larger trial. One reason bayer drug had failed was because it blocked proteins in healthy cells as well as cancerous ones; side effects were also present. Human tumours with the mutation, grafted into mice, had stopped growing when exposed to drug. Screened patients first for mutation to determine eligibility for trial. Started first 3 patients on 200 mg/day; after two months, no response/side effects, they doubled it. Two more months passed, still nothing gave 3 more patients 800 mg, the equivalent of dose that stopped tumour growth in mice. In some patients, tumour remained same size; however, tumours had to shrink to qualify patients as. Prepared docs to convince fda that drug should be tested in phase 2 trial.
