Tag Archives: Phase 1 clinical trial risks

A bit too close to the edge

I get my feet wet

I was discharged Sunday. Six pounds lighter and pretty darn worn out after my adventure, but happy to be home. I am back on the antibiotic levaquin, my persistent cough is finally abating and David has made the feeding and fattening of Linnea his pet project.

On Tuesday I returned to Boston for labs, a CT scan and to meet with Dr. Shaw. My ALT/AST are continuing to come down, but are still elevated. The LDK 378 will be held for another week and I will have labs on Friday and again on Monday to make sure the downward trend continues. Although I don’t have the radiologist’s report yet, Dr. Shaw reviewed the scans and feels that the activity in my lungs is at the very least stable, and at the very best, maybe even slightly improved.

All of the tests for outside causes have been coming back negative, as anticipated. When I said I was being test for Hepatitis, I should have specified viral Hepatitis. I have learned that hepatitis is a generic term for liver injury and inflammation. Drug induced hepatotoxicity (pronounced (hep′ă-tō-tok-sis′i-tē), and referring to the capacity of a drug or other agent to induce liver injury) is also referred to by the acronym DILI or drug induced liver injury. It is relatively uncommon, “DILI in the case of any single drug is thought to occur approximately in one per 10 000–100 000 treated patients.”  (from Pub Med Central). However, I wonder if that statistic is pertinent to clinical trials. Phase I of a trial, such as the one I am enrolled in, is to determine at what level a drug can safely be administered, and to do so through dose escalation. Although my ALT/AST were significantly elevated, the fact that my liver function was never compromised is an important distinction, not just for me but for the the trial itself. Severe DILI is defined as liver failure or death, two bullets I obviously dodged. However, it would seem that the careful monitoring I received was not misplaced, as evidenced by this article in Medscape about drug induced hepatitis.

Although I would like to go back on trial as soon as possible, I have some trepidation as well. There is the possibility that when the LDK 378 is reintroduced, the scenario may be repeated. Of course, the only way to find out is to try, and I assume I would be monitored even more closely at rechallenge (the opposite of dechallenge, or holding of the drug).  The FDA has published a Guideline For Industry that specifically addresses the issues surrounding DILI in a clinical trial setting, should you be interested in the specifics.

In the big picture, it is not so very important, but I’m sad to say that my drinking days might be over; I can’t even look at a glass of wine anymore. And I had such a talent for (the wine tasting) and sublime appreciation of. Oh well. I actually awakened in a bit of a cold sweat last night because I dreamt I’d had a cocktail.

So, in conclusion, I came out on the good end of a bad week. I am both highly encouraged and deeply anxious about where we go from here. And I will keep you posted.