Neratinib Clinical Trials

Weety - The concept that Neratanib crosses the blood brain barrier is one of the reasons I was so interested in this trial, and one of the reasons I'm so disappointed since I seem to be getting the placebo.

Kristy - Glad to hear that your side effects have lessened so much!

Thanks, Anne. (That's my daughter's name.) I had very few side effects from TCH, so maybe we are the lucky ones who just don't get the negative reaction from these drugs.



But if I am one of the women getting the plcebo, I know that I'm contributing to bringing this drug to market. No matter what, I hope it's a valuable treatment for Her2+.



Sue

Well, after a couple of weeks of my Oncologist office working with Wyeth, they have decided to try some other pre-meds for me to see if they can control the side effects better.  With that my Oncologist agreed to let me try one more time.  I will be getting a Sandostatin shot once a month (this has to be administered the first time about a week in advance of re-starting the trial meds). And then I'll be taking compazine and lomotil before, during and after taking the trial meds each day to see if all of these can control the vomiting and debilitating diarreah. I'll keep you all posted on how it goes - I'll be getting my first shot today and re-starting the meds at the first step-down dose next Wednesday.

I cant tell if im on the placebo.  The first few days i felt a little nauseous, have been feeling more tired, and have had bone pain like i did on herceptin, but no diareah.  Oh well, either way im happy im in the trial, and am helping get this drug on the market quicker, so i will keep taking my six pills a day

Laura

Hello!  I am brand new here.  I started the Neratinib trial last Wednesday 2/10, and my side effects were immediate.  Dibilitating is not the word for it!  Yesterday, I started the Immodian AD and I was told not to take the drug until I stabilize.  I'm going to the Dr.'s office this afternoon to check on dehydration.  I am taking the drug at night along with my other meds.  Do you think that makes a difference, taking at night time?  I feel that having an accident, I'd rather it happen at night or early morning rather than in the daytime.

I was diagnosed 2 years ago on Valentine's day.

First of all stay away from all dairy product.  If you are unsure if something is dairy or not ask.  If you miss a glass of milk, there are good soy drinks available that are very healthy.  And Kristy is correct that you need a good meal to take your pills with.  I take mine at noon as that is my best meal of the day and at the most regular time.  I prefer to have the side effects of diarrhea during waking hours.  Also you will need to make sure that you have not contracted a stomach bug of some sort.  Your Dr. and nurse will help you through the problems you are having.  Don't worry about dieting for the year as your body needs the energy that you get through your diet.  I have some minor side effects and would not change anything at this time yet.  I have been on the trial for 5 weeks now..Wishing you all the best.  It can be tough but you know the saying "when the going gets tough the though get going."

Well, I'll give it one more week but as of today my thought is that I can't continue... not that I don't want to but even at the reduced dosage the s/e's are such that it almost makes it impossible to work or have any kind of life... can't schedule meetings because I don't know how long I'll be able to stay in them, can't take the grandkids out unless there are washrooms every step of the way and the fatigue is leaving me like a wet rag.  I've tried using all the supplemental drugs like Lomotil and Imodium but this stuff just doesn't like me - every time an 'attack' is coming on my blood pressure drops and my big challenge is not to pass out on the toilet.  I don't like the option of not being on the drug and reducing the risk of cancer recurrence but the only true way I could do it would be to quit work and stay at home in the bathroom.  Combine that with a brutal case of stomach flu on the weekend and I'm not in the best physical or mental state...

Cloud - my cancer center doesn't offer it. I have to go to Philadelphia if I want to participate, which is over an hour away and far less convenient than my large, new cancer center where all my treatment is. However - when I asked them why they weren't participating, someone (NOT my onc himself) told me that they do not take on any trials that they cannot make a profit on . (!!!!)  He said that the NCI trials and some others are profitable but the ones the drug cos are doing are not so much (I think I got this correctly).  He said that the large teaching hospitals in Philly that have med schools attached are making money in many other areas so are able to offer these, but mine is not like that.

So I don't know if this sheds any light on your situation, but I found it interesting. I guess money talks in ways we don't always realize.

I am completely willing to go to Philly for the quarterly meetings, but i am going to clarify from them before I sign up as to whether I will need to get my lab work done up there and go there if I have any of these SE's I've been reading about on here. I can't be running up there continually, so I need to know ahead of time.

Good luck and let us know what you find out.

As I reported last week, I agreed to give the trial meds one last good effort - however, even with all of the pre-meds onboard I still can't tolerate the neratinib.  The clinical trial nurse said my sypmtoms were the most severe that they had seen and it almost appeared as if my body was having an allergic reaction to the medicine.  The first time, I took the neratinib for 2 days before any sign of diarrhea and then it was controllable with immodium but a week later it came back accompanied by vomiting.  The second time (after a 2-week break) I started throwing up within 9 hours of taking just one dose with the diarrhea starting up a few hours later.  This last time, even though I took compazine and lomitil an hour before taking the neratinib, the vomitting started just 3 hours after I took the neratinib.  I was taking the neratinib in the evening with dinner so there was no doubt I was eating enough with it and I was careful to have small bland meals with no dairy.  Given my experiences with this trial, the only advice I can give you is to weigh your quality of life against the potential benefits - I personally gave it every chance I could so that I wouldn't wonder if I had failed to give my self the best chance for survival.  But when all is said and done, my body just won't tolerate this drug and I just can't go on with the trial.

I am surprised that Wyeth hasn't done something to stop the SEs.  My doctor took me off for one day and I felt great the following day.  This is fast acting stuff!  I started again night before last, made it through yesterday with immodium and a few runs to the bathroom.  I had a big bowl of rice last night and today, all is well.  I am about to eat another big bowl and hope for the best.  I am afraid to add anything to my diet just yet.  I've lost three pounds since last week when I started.  That is welcomed, however I know it is all liquid loss.  I am drinking as much liquid as I can to stay hydrated.  I thought about buying some depends, but I can't stand the thought.

That is a funny story Weety.

Something that occurred to me and I thought I would pass it on.  My side effects have been very light.  A few days before I started the trial my internist put me on a low cholesterol/fat free diet.  My husband thinks that this is the reason why I haven't been bothered too much....no cheeses, no milk except skim and no fat.  I eat several light meals each day instead of a few larger ones.

I'm hoping that you ladies begin to feel better.

Anne

Evening All! So,I took my first dose this morning and I don't know if its the drug or a flu,but I've been nauseous for most of the afternoon.I didn't think side effects would occur this quickly. Any thoughts? Also,a few of you mentioned the blood brain barrier and herceptin-could someone enlighten me?TY

rebekah 

Kristy-Thank you for the information.This is something that I wasn't aware of; or something I may have missed or tuned out. I should've been the poster child for those needing a 'buddy' at all appointments.

So,day 2 and it took about 3 hours before my stomach rejected the drug and I was throwing up. I'll try taking them in the evening-might be easier on my stomach than the morning. Really didn't expect to have side effects so quickly....... 

Thanks Kristy, I normally have the innards of a steel trap but not with this drug.  I have had no other issues with even my chemo treatments (FEC and Taxotere), Herceptin or Arimidex.  I'll have my followup tests next week and then actively watch the results of this trial.  Good luck to you all.

And, hi to Anne.