Starting Clinical Trial for PTEN and ... - Understanding Cli...

Understanding Clinical Trials
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Starting Clinical Trial for PTEN and P1K3C defects in Prostrate Cancer tumors

In 4th year since metastasized PCa initially diagnosed. This is my 3rd Clinical Trial, NCT01884285, Phase 1 evaluation of AZD8186. My first clinical trial was with Galeterone, dropped after 31 days due to Uticaria reaction. 2nd trial was on Enzalutimide, which went for 33 cycles (4 week cycles) and a follow-up solid tumor biopsy. Stopped Enzalutimide due to extreme fatigue. Biopsy genomic analysis showed PTEN, ATM, P1K3C*, and other related defects. The AZD drug is being used on other cancers, too. (Squamous Non-Small Cell Lung Cancer (sqNSCLC);

Triple Negative Breast Cancer (TNBC). These genomic areas are the ones that control cancer cell life and death pathways. You can see more of my history by checking my other inputs.

4 Replies

Cool! As of a few years ago, there were no trials that targeted PTEN. Times change.


The bad news is I had to come off the trial drug, yesterday. After a little over 4 weeks, my Liver Enzymes went sky high. ALT 648, AST 371. Have to punt and find a new course of action.


Well, my Liver recovered from the Drug Induced Liver Injury (DILI) and I have restarted the drug trial at half the original dose. Now 60 mg, twice a day, along with close monitoring of my liver enzymes. Let you know how it goes.


Well the re-challenge did not succeed. After six days back on the drug, my Liver enzymes, ALT and AST jumped back up 5-6 fold. Have to shut it down and seek another course of treatment. A little disappointing, but that is what Phase 1 trials are all about.


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