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Saturday, June 22, 2013

Clinical Trial Phase 2 LDK378, Day 1 Day 2

LDK 378 Day 1
Yesterday was a almost a full day spent at Stanford Cancer center where I had to get up way early for a CT scan, fasting, blood draws (twice), and EKGs (twice), as this was the protocol, requirements , guidelines and process of my first day of the Phase II, Clinical trial of LDK378. This trial just started the end of May and to begin the application process, I had to stop taking Xalkori for about 3-4 weeks ago. It was a LONG day at Stanford and my day started out at 7AM, driving on an empty stomach.
Afterwards by 2PM, after having swallowed 5 giant pills of 150 mg each (for a combined 750 mg strength) in front of the nurse, I was finally done. But feeling sleepy, hungry, exhausted, I really wanted to head home for a nice nap, but, nope, I had to head into work.
Normally my Stanford appointments are on Wednesdays, but due to the CT scan requirement, for this and the next appointment, it was moved to Fridays.
Getting accepted into this clinical trial took 3 weeks of hard work of labs, MRIs, bone scan, and of course a weaning of Xalkori and a lot of  paperwork. If you Google LDK378, there's been lots of great news on how great this new second generation of ALK pill is. The results turned out so well in its initial Phase 1 trial, that its "Data show 60% overall response rate in 78 patients with ALK+ NSCLC taking LDK378 at 750 mg; will serve as basis for first filing in early 2014 http://www.novartis.com/newsroom/media-releases/en/2013/1706664.shtml.
I hope get the excellant results that others have received. Praying hard and dreaming big!

My reaction to LDK378
So in my day 1 of this LDK trial yesterday, after swallowing all 5 150 mg of LDK378, which required lots of water drinking and forcing it down my throat as the pills are like horse pills, pretty big to gulp down, I felt fine initially.  But I knew, eventually, my body would vomit it up. And by 5 PM, barely making it onto my driveway, I had to run to the bathroom and violently, vomit. I knew, for sure, my stomach would not tolerate this 750 mg, or 5 pills down easily. and that was that. Back to the feeling miserable of vomiting episode again.

Day 2 LDK378 
The directions were that I was supposed to take all 5 pills each morning before eating at the same time everyday.  But, wait, an empty stomach first thing the morning? That would guarantee a repeat vomit episode again for sure. So, I cheated and gulped it down after eating a little breakfast of bagel instead. But, within 2 hours, my stomach would not take it and again, vomit happened again.
I will have to discuss these vomitting episodes to my Dr Monday. Until then, it's a bummer, the 750 mg or 5 pills each morning, isn't working for me. And I was really, really hoping, my body would take it.

What now? I suspect, my Dr. will allow me to lower the dosage or split up my pills throughout the day. Like, take 2 in the morning, 1 in the afternoon and 2 at night.  That would still be equal to 750 mg daily.  On top of that, did you know that I have my "regular", routine of 4 other types of pills I also take daily too? Yup. I  do. So, if you want to know how many pills I am popping each day, with thie LDK378 of 5 pills per day, I pop a total of 9 pills daily! OMG, that's a lot of me and if anyone knows me, knows that I don't like to take pills. Those other pills are: 1 Baraclude (for health liver enzymes against Hep), daily multi vitamins, vitamin C & D, and lastly, my low dosage of birth control pill (as required per the clinical trial).
I hope my Dr will allow me to split up my LDK378 throughout the day or lower my dosage. Will update you next week. Lots of Love.

4 comments:

  1. Fawn its really good trail that you have spend time in cancer center and you observe many things and as well you have also learn allot of things about life that how life is important and how we should utilize it.
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  3. Great observation, I salute you for being passionate in handling things like that, how I wish I can do the same, well we all does.
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