Phase I

The last couple of days have been hectic. Susan, Nathan, and Lauren were off to NYC this morning after getting the go ahead to come yesterday. While it was had getting everything ready and the upcoming week+ is likely going to be hard on everyone, especially Susan, Nathan, and Lauren, it is really a good thing to be getting started on something.

The treatment Nathan is starting next week in NY is a Phase I clinical trial. The drugs being used have been given in clinical trials before, but not together. I haven't found any description or information of the trial online.

From documentation on the FDA's web site.

Phase I Clinical Trials

The purpose of a Phase I clinical trial is to find the best way to give a new treatment and how much of it can be given safely. In a Phase I study a new treatment is given to a small number of patients. For a new drug, the study starts by giving a very low dose of the drug, then the dose is slowly increased as new patients enter the trial. The dose can be increased by giving more at one time or by giving the same dose more often. Physicians watch patients carefully for any harmful side effects. Although the research treatment has been well tested in laboratory and animal studies, the side effects in patients cannot be completely known ahead of time. Phase I study effects may involve significant risks for this reason. They are offered only to patients whose cancer cannot be helped by other known treatments. Phase I treatments may or may not produce anti-cancer effects, but some patients have been helped by these treatments. Once the best dose is chosen, the drug is studied for its ability to shrink tumors in Phase II trials.

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