Clinical Trial - AKT Inhibitor (MSC2363318A) and Tamoxifen

I'm sorry I've been very remiss in updating this thread.  I'm going to add a few details now.

The trial drug is MSC2363318A, a Dual p70S6K/Akt Inhibitor (I have the Akt mutation) and it is taken with Tamoxifen which I have previously taken as my first line of treatment almost 4 years ago.  I had a good run on Tamoxifen alone back then.  About a 18 rounds.

The cycle for this protocol is 21 days.  I take the trial drug for 15 days and then 6 days off.  Tamoxifen has no break.  I maintain a dosage diary and a what I lovingly call a Poopie diary where I have to keep track of how many bms I have per day.   The trial provides the diaries.   The dosage diary is just a record of the date and time you take the protocol and how many pills you take of each part.  The study drug is 3 pink capsules.  Tamoxifen is 1 white chalky pill.  I'm pretty consistent on when I take my pills.  Usually 7:00am. 

You can eat 2 hours before taking the protocol or take it and wait an hour before eating.  Other than day one of the cycle I take it in the morning and go back to bed for an hour.  I experience mild nausea and a little diarrhea on the first and second day of the cycle and after that I'm normal.   

Since it a trial scenario I have to take the first dose of each cycle in clinic (at the hospital).   The way that day goes is as follows:

I have to fast for blood work so usually the last time I eat is around 9:00pm the night before.  I have an echocardiogram at every new cycle.  That's in the morning and it takes about an hour.  I don't like the echo because my breast tumor is right where they have to press with the probe. It is a little painful when they press on it for 30 minutes.  But you gotta do what you gotta do.  Then I go for blood work - usually 10 or 12 vials of blood.  Within a half hour the blood work is back and I meet with my MO and trial team.  I hand in my protocol drugs from the previous cycle along with the diaries.  I have 3 ekgs performed.  We discuss how I'm feeling.  My MO looks that the results of the echocardiogram and ekgs and if all is well he signs off on the next cycle of drugs.  By this time it is usually near noon or 1:00pm and I haven't eaten since the night before.   I have to wait for the pharmacy to prepare the protocol and sometimes that takes an hour.  Once I get the new cycle drugs I take them in front of someone in the trial team.  We fill out the dosage diary.  And then I drive home which is just about 45 minutes to an hour.  I get home and EAT and usually within an hour of eating the diarrhea comes.  It's not bad, it's not all day like some other protocols cause, and has been getting better each cycle.  

I don't get fatigue from this drug unless I over exert myself.  I work from home because the hour and 45 minute commute by train is exhausting and driving in is no better and could take longer at rush hour.  I'm lucky that my employer has no problem with me working from home.

I do get little tiny itsy bitsy pimples that are barely noticeable on my face.  They come and go.  Some days there are none and other days there are 3 or 4 of them.

This trial drug also does not affect white or red blood cells or neutrophils so there's no neutropenia to worry about.  That's probably why I am not as fatigued and have more energy.   My blood work is pristine as they like tell me.  As for tumor markers -the CEA is crawling up a bit but it's still single digits.  The CA 15-3 is in normal range.  My TMS have never really been helpful. 

There are few other details I want to share but I have to look them up.  There are some restrictions to being on this trial.  I'll back with that info.

Quick update on my trial. The trial is closing. Apparently I am the Lone Ranger now. It’s still keeping me stable so I continue on. I never really gave it much thought - meaning what happens when a trial closes. I’m still not really sure - they are keeping me on the protocol so I’m happy about that. The SEs have been very tolerable. At least they have been for me. I get mild nausea when I go too long without eating and then take the drugs; I also get some diarrhea the first two days of the cycle and constipation the last week when I’m off the study drug but still on tamoxifen

MaryLark - I'm kicking myself for not getting more details about the closing of the trial.  My impression was that it was no longer working for the others in the trial.  I'm the sole participant with benefit from the protocol.  But I will get a better answer next week when I see the trial team again.

Thanks for checking in!