Neratinib Clinical Trials
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I havent heard anything about the trials closure prematurely for the reason of adverse reaction, but will ask my study Doc or nurse the next time I see them, maybe possibly due to the expense or a new arm study or they may simply have enough participants ! what-ever the reason I am keen to find out also, good-luck heathermcd, the drug companies Web gives good reading, I hope that helps, Pfizer.
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Ladies, I don't know what this means for women already involved in the study, but here's the latest news:
Puma Biotechnology Announces Licensing Agreement with Pfizer for the Development and Commercialization of Neratinib, an Investigational Pan-HER Inhibitor; Closes $55 Million Private Placement and Completes Merger PR NewswireLOS ANGELES, Oct. 5, 2011LOS ANGELES, Oct. 5, 2011 /PRNewswire/ -- Puma
Biotechnology, Inc., a development stage biopharmaceutical company, today announced an agreement with Pfizer to license the worldwide commercial rights to neratinibUnder the terms of the agreement, Puma will assume sole responsibility of global product development and commercialization of neratinib. Pfizer will be entitled to receive payments upon Puma's achievement of certain development milestones of neratinib, as well as royalty payments for any sales of neratinib.Puma intends to focus the development of neratinib on the treatment of patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy. Neratinib has previously been tested in numerous clinical trials both as single agent and in combination with other anticancer drugs in this patient population. In these studies, neratinib demonstrated substantial clinical activity and was well tolerated. Based on the results of these studies, Puma intends to initiate clinical trials in this patient population in the first half of 2012.Prior to the licensing agreement with Puma, Pfizer had been sponsoring two clinical trials of neratinib: 1) the NEfERTT trial, a Phase II randomized trial of neratinib in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of patients who have not received previous treatment for HER2-positive metastatic breast cancer, and 2) the ExteNET trial, a Phase III study investigating the effects of neratinib after adjuvant trastuzumab in patients with early stage breast cancer. Consistent with Puma's strategy to refocus clinical development of neratinib in patients with HER2-positive metastatic breast cancer who have received prior lines of trastuzumab-based therapy, Puma intends to stop enrollment of new patients and proceed with winding down both trials. -
Brain-ova-load !!! Thank You RKR for the up to date information, much appreciated, and very interesting stuff, along with some recent research findings with the opinions to the effectiveness of Anthracylines, for early stage breast cancer treatment. " may need glasses after that post " !
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Sorry about the crazy large font in the previous post; I was cutting and pasting from the newswire, and couldn't make it any smaller! So, it sounds like neratinib will be marketed world-wide. Of course, in the USA it does not yet have FDA approval. It will be interesting to see what this means for women who are interested in participating in the study for no charge, all tests included, etc.
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Apologies for my ignorance, I'm new to try to look at clinical trials. RKR, is the trial above the same as the ALLTTO trial? If it is then sounds like I can't get in if they are closing it down and only concentrating on Stage IV. Does anyone know of similiar trials for non Stage IV women. I tried seaching on the NCI website, but I'm still figuring out how to decode it all.
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Hello, friends. I got a call from my study nurse yesterday asking me to move my appointment forward. I'm going to finish a week early and they want the data from the last quarter because the trial team is coming in. Apparently I'm the last patient in the study in this office. I also found out that I get annual follow up now, not every few years. She said they are going to pursue FDA approval as they have had great results.
To celebrate, I incurred the tummy wrath and developed the diarrhea.
I see them in a week or so and I'll post what I learn.
Warmly,
Cathy
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Reading mama, I am told they have closed this trial to new participants. I do not know if there are other trials.
Most warmly,
Cathy
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I still wonder what this means for those of us early into the trial !!! Have not heard from my study team for a while so Im guessing they are sorting out the politics of it all, hoping they have stopped the trial like Herceptins early reasoning of positive results and not bad ones, and as you mentioned RKR due to the amalgamation of drug companies. I started taking an anti diarrhea tab at the same time as taking the trial drug and it seems to work for me so far, resulting in some normal bowel movements, but I have been told to take it only when I get the D, which is all the time anyway.
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Just got a call from the clinical research nurse at Vanderbilt-Ingram and she said the trial had closed because of such good results and they were seeking FDA approval. I wonder how long that will take and also am curious who the Neratinib will be offered to once FDA approval is reached. I asked if there were any other trials I would qualify for and first she said the Metformin trial but then said I was too far out for it.
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I haven't visited here in a while - this is such exciting news! I was in the trial from Jan. 2010-Jan. 2011 (they were still taking node-negative when I entered.) I think I got the placebo since no big D issues, but I'm still glad I participated. What great news for all of you who suffered from the side effects - apparently, it works!
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So, I was admitted into the trial (one of the VERY last) and I will start the drug next week. Well, hopefully it will be the drug. Keep fingers crossed and prayers comin'!! I am really confused about the last few posts though. Why is Pfizer selling the drug if it is doing so well? They are still seeking royalties, but they aren't going to make the full-monty on the drug if they are selling it.....please help ratify my business sense...would a money hungry drug-company sell a drug if it was SO promising? I have really high hopes for this drug...but i'm confused about the statements from nurse coordinators indicating they are stopping the trial because of success and seeking FDA approval. I thought the trial was stopping because Pfizer no longer controls the drug?
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Can someone offer a quick recap of these latest updates re: the trial? I've been on the trial since May, 2011 and see my oncologist next week for a regular study visit. I'd love to have a better understanding of what's going on. I've been reading these posts but if someone could summarize in a few sentence, I'd really appreciate it!
At what point will they offer the drug to everyone since the results are apparently good--AFTER FDA approval? And how long does that generally take?Thanks!
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Hi, Friends! I'm not sure I can summarize, geminihalf, but I think the results of the trial have shown so much promise that the owner of the drug plans to license it to another pharmaceutical company who is more able to bring it to market. Usually, the reasons for choosing this path are financial--they will earn more, and earn it faster through the licensing agreement with a smaller and more agile company than if they tried to dedicate the resources themselves. Pfizer has big expensive resources and many more projects that may be more profitable, from which this one might distract. Puma, the selected company will have more hoops to jump through at the FDA level, but it sounds like their intention is to focus on a segment of the population of patients previously treated with Herceptin, and not on the combo protocols.
It will take a while for them to conduct more studies and to decide the intended protocol, that is, to whom this will be adminstered and when in the treatment cycle. While the FDA trials are underway, the payors around the world will be looking for evidence that this can and should be prescribed, and paid for by insurers, because it is less expensive and more effective than the current standard of care, in the long run.
So one reason for the licensing is that it makes the drug more available faster if its costs are kept under control.
Anyway, no more enrollment in the most recent trial, for those who have already had Herceptin, because they already know that it works well enough to begin the marketing process, and trials are expensive. I doubt that it's in the range of compassionate care because the trial was not for curative properties, and they are going to continue to study the trial subjects.
I learned that they are increasing my follow up schedule to every four months. Because the Her2 women who are going to have a recurrence usually have it in the first four years, they are, I assume looking for the recurrence thresholds to compare them.
In my subtrial, they did additional tumor studies, and recorded details of my tumor type. I believe they will be looking for correlations between who gets the best results from Neratinib, and who doesn't get the desired outcome, and that probably has something to do with the tumor. That may lead to the protocol.
That is everything I can imagine, but I'm not a health professional, nor an employee of Big Pharma. I do know that the FDA process can take a long time, but that if this is a really good drug, there will be more info every few months that will support getting it into the market faster, which means the cost of development is recovered faster and the profits come in faster.
On another note, I am done and it's a strange feeling. I had a lot of fatigue the last few months of the trial, and I'm paying attention to what feels like looming constipation. Even though I did not get much of the Big D, I did have a change in bowel habits. I had two years of Herceptin and three weeks later entered the trial, so I feel a bit like I'm having some withdrawal, at least emotional withdrawal.
Warmly,
Cathy
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Cathy--
Great information, thank you! You sound like a health care/ pharma pro! It will be very interesting to see what tumors neratinib works well on. I'm about midway through the trial--have a follow up appt with the oncologist tomorrow. So I'll add this topic to my list. I don't know if I'm on the drug--like you, I haven't had the big D EXCEPT when I took a particular antibiotic. Then it was unbelievably bad for like a week. Plus I've had some other bowel issues, which kind of makes me think I might be on it. But who knows--the doc won't speculate. Guess I won't blame him. It will be 1 year in December since Herceptin ended for me.
That's also good to know about the 4 year window for HER2 women. It's something I've heard a lot about on these boards (2-4 years). My doc won't say one way or the other, but It will be good to have in the back of my mind. My chemo ended in April 2010, and I was diagnosed in Oct 2009.Thank you!! GeminiHalf
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Started the trial today. No D yet, but I'm still hopeful. Not that I want to spend the next year on the toilet, but I would SO love to get the benefits! Come on big D!!
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wow, thats interesting that they are still enrolling in the current trial.
I love hearing that the drug works so well! Hopefully, it works well in all of us! -
They actually aren't enrolling anymore. I was able to get signed up right before the trial ended. So glad that I beat the deadline!
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Thank-You, Thank-You, Thank-You, cbm You have explained the recent events in understand-able plain english, abit like most of the pieces of the puzzle are now in place thanx.
Is the recurrence threshold that you speak of, the same as Herceptins ongoing data comparatives of what works for one, does not work for another scenario ! as you mentioned the correlation between tumor markers response to Neratinib ! I am also interested in the response pathways inhibitor kinase, how does Neratinib work on the bad guys ? the mechanics behind it and what its acting on to cause diarrhea as one of the side effects! my understanding is that Neratinib reacts differently to HER1, HER2, HER3 and HER4 why ! and is it to do with the amount of receptors on HER2+ reacts better to the more +++ they are ! I hope I didnt put that ass-up !!!
I think I have the D under control now with daily anti-emetics, but these nose pimples and bleeds are driving me crazy !
I wish Nanotechnology would arrive sooner than what is predicted, but still I am so deeply grateful for all the research-pathologist, scientists and all involved in closing the gap for a curative means.
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Heathermcd - most of us got the D after a few days - really bad for me at first but better now - I'm 1/2 way through. Nose pimples and an occasional mouth sore too... Lost around 15 lbs from lack of appetite - same thing on Herceptin. I'm not looking forward to ending. Just starting to get a little neuropathy when I sleep but it may be related to tension in my neck and being overdue to see the chiropractor.
K
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Hi, KCFS, I think that they are looking for (among other things) commonalities among the women in the trial who got Neratinib but recurred nonetheless, if any. Also, commonalities among the women in the trial who recurred but did not get the drug, versus the population who did not recur and who got the drug. I do not have any idea how the drug works; I know the words, but I'm not a science girl, more of a business girl.
I was told by my p/a a long time ago that the notion that Herceptin works better on the higher CEP17/Her2 ratios is sort of a red herring. She said that it is simply logic--that the proliferation rate is higher so the drug is more deadly to more cells, whereas in my tumor, for example, HER2 is not likely the only, or perhaps even the primary cause of cell proliferation.
Most of the pathology information collected and used is based on the numbers of receptors--but the unifomity of the tumor is not necessarily constant. In my case, I had a mixed tumor, made up of both IDC and ILC, as well as DCIS and LCIS. 90% ER and 90% PR, but light on the Her2, at 2.4 (CEP17/Her2 ratio). We know the ILC is no doubt ER+, but the rest is sort of soupy. The IDC might be ER-, and I could have some triple negative cells, some Her2+ with no ER or PR sensitivity, or any combo. The less uniformity, the more speculation on the risks.
Heather, I did not have diarrhea, but I did have other symptoms. About ten percent of us will not get the diarrhea, although in my case it showed up almost every time I took Keflex. I did get significant neuropathy which began exactly seven days after the first dose and then stopped progressing for a while, then progressed very slowly. 'I had no Hercpetin side effects other than the drippy nose.
Incidentally, I have been done for seven days, and I seem to have stopped having hot flashes.
Warmly,
Cathy
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Cathy - thanks for the info. I was also Mixed IDC ILC and haven't seen many others like us.
Karyn
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Thanks again Cathy, I am at the beginning stages of decoding my histopathology report as with finding in mine, all of what you have described in yours, and I understand most of it. I have stronger HER+ markers, 6.5mitotic nuclear activity CEP/Her2 ratio, my tumor also had much DCIS, hence why I ask the question ! so I thank you again for taking the time to answer so promptly, gosh I don't know what I would do with out people like you that help in this way, because for me your help, helps me move forwards to continue a pro-active educational approach with a positive, self help attitude, my weapon of choice for this battle.
That's funny/strange you mention your hot flashes ! for 15mths through treatment, chemo, rads, herceptin, I had intence hot flashes every hour or so for 10/15 min, I am 45yrs of age, then like over night they stopped, which lasted for 3mths, now they have re-started faintly/weaker, but noticeably they are there, and now the intense sweating again at every strike, so here we go, turning the heater off, then on , then off, then cloths on/off, I get lots of exercise this way, ha ha.
Hi kward70, I hope your chiropractor is gentle, I have not so nice or calm memories of a chiropractor with harsh jolting actions that is enough to fracture us chemo girls bones to mash potato, please take care.
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some grumbly tummy this morning, but I think its because i'm constipated :-( Thats probably not a good sign.
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Actually, constipation is on the list of side effects.
Cathy
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Heather - my tummy would be grumbly the day before I had D - active bowels I think. You may be different but I thought I'd add my experience
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Karyn - thanks for your insight. I'm so hopeful that I got the drug. Every rumble is just hope. I'm sure that my stomach rumbles all the time, i'm just paying more attention to it today. I know that either way my participation will be helpful, but my age and risk really make me want to be one of the 50% that get the actual drug. Keep your fingers crossed. If anyone else had any pre-D symptoms please share...trying to keep up the hope that there'll be a sign indicating that i'm on it!
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Fingers crossed for you. Grumbles always precede D for me!!
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Normal, hard stool this morning :-( Day 3 of pills. Did anyone take 4 days for the D to kick in? I'm starting to think its Placebo for sure.
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Heather - I think mine kicked in around day four... Some have it earlier some later, others will report no change in stool at all.
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Heather, I did not have the diarrhea except when taking antibiotics, and then I could not get rid of it. I did have other symptoms--neuropathy, for one--at around day 7, they excalated and then abated at about three months. There was no one on my team who did not believe I got the drug. Really, really, not everyone gets the diarrhea.
My gastrointestinal doctor's p.a. who had to deal with my antibiotic induced D told me that in these trials they may introduce different compounds at different intervals, also. When I complained about the unabated diarrhea, they thought perhaps I had started a new bottle, and had a new compound.
When you go to your follow-ups, they take your pills and give you new pills. So you don't know at any point exactly what you are getting, according to her.
Warmly,
Cathy
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