Neratinib Clinical Trials

Cathy

That's a good point about the new pills after each check-in.  I had my 12 week follow up yesterday.  The ladies on this thread no more about the latest with the trial than, I think, my coodinator! She confirmed what has been said here.  But said it doesn't really affect me, since I have about 6 more months on the trial. 

I asked about the diarreah and she confirmed that not everyone  gets it. I told her that other women on this thread experienced SEVERE D while taking Keflex (my experience) and she kind of poo poo'd that (pardon the pun).  Anyway, I have sensed some potential SE's come and go when I get the new pills.  Who knows, I may end up not having gotten the drug at all.  I guess at some point they will un-blind the study (possibly before FDA approval?) so we'll find out. And if the results have been good, we'll all get the drug--though I wonder if they'll give us the drug if we are more than 1 year out from Herceptin ending...

Kathleen - this study has already ended to new participants. I believe Puma is going to start new trials early 2012.

So, its day 6. No side effects at all over the weekend. This morning i kicked the side of the bathtub and noticed that my toes felt "funny" as I type this i'm feeling a little bit of neurapathy in my fingers. Then...out of nowhere....loose stools!!! Just as I had lost all hope that I got the drug...hope is renewed!

Heather - if you cont to have D please call your dr. It can be difficult to control in the beginning.  I had 5 days straight but I've been better since.

Hi ladies, yeah either way alot of it is guess work for us on the single arm Plll-study-trial, with-out existing tumors to gage shrinkage or stabilization, thankfully so.

I have also wondered about the batch changes in bottles and have been silly enough to break one in half to see if the colouring changes, stupid really ! got to slap myself sometimes.

heather I was like you and went till day 6 or 7 until the loose stools came, then with out warning whammo, big momma D had arrived, I was still not convinced, I thought, maybe the placebo has a type of sugar content that has a natural D effect on our digestive system, Im still guessing !

I think we should also keep an eye on our blood WCC count as Neratinib is a chemotherapy drug, cytotoxic ( 0.8.01 ) according to Pfizer data, so its probable to slowly have an effect on our Neutrophils as well as the fact that the food we are eating is not absorbed in time for nourishment with out anti-emetics.

Kathleen I just read that the trial was officially meant to end in June 2016, if it stops now, that means it didnt even get half way.

hmm...makes me wonder. My onc was SUPER specific to tell me to start the new bottle of pills from my last visit and not use any more from the old bottle and to bring that old bottle back next visit. In retrospect, the pills are all the same mg, so maybe they are all the same thing. I agree with Karyn...they would probably be really clear about journaling the differences in side effects in bottles.

HI Ladies,

Okay, I have read here that the study is closed and they are not taking any new participants. 

Back in May, I inquired about this study, and had all the paperwork and contact info, but didn't pursue until last week.  I emailed the person and she said that the trial was still open. 

Then, the next day, they called me for an appointment next Monday to meet with the Dr. who is running this trial.  So, it will be interesting to see what happens at that appointment.  I will post back.

V

Stupid question... but why do you need a double blind half drug/half placebo??  I mean, if you aren't in the trial, you aren't taking the drug... so couldn't everyone IN the trial get the drug and be compared to those NOT in the trial.  Silly, I know...  our follow up is different and more detailed... I'm just upset because I am 93% sure I have the placebo!! 

I dont think they can tell anyone until the study is "unblinded" for everyone. You are right about the placebo effect....I have a friend who is a trial reseacher for big pharma and they have to take a 30% placebo effect into account. Thats really fascinating to me. That almost 1/3 of the people can change an outcome with mind over matter....HUGE frontier in mind body medicine I wish could be studied by someone with big dollars.

My neuropathy got worse on the trial and had some foot and joint pain that has not recurred since being done.  I do still have a bit of neuropathy but, I think this is permanent from the Taxol.  I did NOT have a problem with D.  Stools were toward  loose a lot of the time.  After I stopped (mid Aug) I had constipation and am getting back to pre trial normality.  Hot flashes were not consistant  I had a couple of months during the trial when they lessened.  After I quit the pills I still had them bad and they have gone now and I am now menstrating.  I guess time will tell on the hormonal fluctuations.

Hi All, 

Just got a phone call from Trial nurse and the study is closed in Seattle as well.  Oh well.....  part of me really wanted to join and part of me was on the fence.  Well, the decision was made for me.

V

Oh wow, where did you hear about the fda rush for approval? Very cool...as I spent all night unable to sleep with a gurgling tummy!

yes, true thanks geewhiz, how-ever I did mean that it looks like that is one of the reasons for stopping the trial prematurely, from early results seen, read review somewhere, medscape, pharma-letter, all still speculation I think, and yes I should be sure where I read it before making that statement, sorry I didnt take note because its so many years before we get to where you are, will find out.   

whoops, NDA (new drug application) not FDA, chemo-brain strikes again ! Thank you again geewhiz

Wow, must not be on the trial. My appetite is still there. I must be the only one gaining weight on this trial :-) Possibly an indication I'm not on the drug?? I was on Herceptin too, same thing. Had bad acid reflux toward the end, but could eat pretty well otherwise.

gemini - I wouldn't interpret appetite as a sign... Just one thing I noticed.  I seemed to have plateau'd out and my weight is stable now.  I also had other things going on in my life which may have effected the weight... I got divorced during chemo (found out my husband was having an affair), my dad died during chemo, and I've dated and broken up with others since starting the trial.