Dacomitinib

Hello all;
After almost 2 1/2 years Tarceva resistance maybe occurring for me.So, plan B is to up my dosage back to 150mg from 100mg and CT scan in 2 months. If there is no noticable change then start the process to get into a Dacomitinib trial. If I could hear back from anyone on a Dacomitinib trial I would appreciate it. I would also be interested in Afatinib but as of now there are not any trials in USA and the Novarx trials are also closed.

Thank you, keep the spirit.

Stefano

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4 replies. Join the discussion

I found this post. You might contact decoy1616 or some of the others. I'm not website savy so I don't know how to give you the link to this post but if you type in Tarceva vs Dacomitinib in the find box it should take you to it. Hoping you have good results!!

Tarceva vs Dacomitinib, looking for other Dacomitinib users
By decoy1616 · January 29, 2012 at 6:48 pm · 13 replies
In Non-small cell lung cancer - General
At the beginning of January 2012, I started on a clinical trial for Dacomitinib (PF-00299804). So far, the side effects are similar to Tarceva, including face/neck rash, diarrhea, mouth sores, and mouth dryness. I think that my fantastic nurses are relying heavily, if not exclusively, on their Tarceva knowledge to help manage my problems. As far as I know, they only have one other patient on Dacomitinib. I have seen postings on this website regarding the use of L-Glutamine and Dacomitinib’s more severe side effects. Are there other Dacomitinib users/caregivers out there? I would like to compare notes directly about Dacomitinib reactions. Also, I feel kind of lonely, compared to all the people on Tarceva!

I’m HER2 (exon 20) mutation, adenocarcinoma stage IV, and was enrolled in the phase 2 trial for Dacomitinib after my main tumor failed to shrink from two rounds of chemo. FYI, there is also an ongoing phase 3 Dacomitinib clinical trial for EGFR+ folks who have developed resistance to Tarceva.

Newest firstBy Rigby
Reply 2798052
January 30, 2012 at 8:20 am
Where may I ask is the trial for EGFR folks with resistance Tarceva...Thanks in advance for any info !!!!!

By decoy1616
Reply 2798179
January 30, 2012 at 9:09 am
The Pfizer website lists two phase 3 trials (as examples). One is called Archer 1009 and the other is BR.26. See Pfizer website here:
http://www.pfizer.com/files/news/esmo/dacomitinib_pf_00299804_fact_sheet.pd f

Information on the Archer 1009 trial can be seen here (and locations are listed):
http://clinicaltrials.gov/ct2/results?intr=%22Dacomitinib+%28PF-00299804%29 %22

The BR26 trial can be seen here (with locations, none of which are in the US):
http://clinicaltrials.gov/ct2/show/study/NCT01000025?show_locs=Y#locn

If you search around on that clinicaltrials.gov website, you may be able to find more Dacomitinib studies. Hope that helps.

By Rigby
Reply 2798297 · In reply to 2798179 by decoy1616
January 30, 2012 at 9:48 am
Thanks verry much ..I will let you know if I join one of the trials

By casey21
Reply 2798591 · In reply to 2798297 by Rigby
January 30, 2012 at 11:19 am
Hi

Where is your clinical trial. How do you know you are getting the drug. The trial I read about are double-blind.
I got colitis and an ulcer from higher dose Tarceva and have been on L-glutamine and take aloe vera juice for some months with excellent results and no recurrence. I only take 500 mg Asulfadyne to prevent colitis.

Please write back and I will give you any particulars I can. I need to find a trial as I have started to progress on Tarceva. Please Help.

By decoy1616
Reply 2798898
January 30, 2012 at 1:01 pm
Casey21, My clinical trial is NCT00818441. It is a phase 2 trial, so I know I am getting the drug. You can look up more info on the study at clinicaltrials.gov. I see you are in Brooklyn. In the state of NY, this study is listed as "recruiting" at the Pfizer Investigational Site in NY, NY.

Phase 3 trials, which this study is not, can include placebos and/or be double blind.

Thank you for the information on preventing colitis.

By decoy1616
Reply 2798908
January 30, 2012 at 1:06 pm
Casey21, I'm sorry I left something out: I'm at Dana Farber in Boston. I see on clinicaltrials.gov that they don't actually list hospitals. So, I don't know which NY hospital(s) are offering this trial.

By JTMCP
Reply 2855488
February 21, 2012 at 10:52 am
My husband is in a Phase 3 trial, double blind testing the two drugs you mention. We do not know which drug my husband is taking. He began the trial two weeks ago. His only sympton so far is a mild rash on his back, very mild on his face.

By Lucca
Reply 2859286
February 22, 2012 at 7:52 pm
What dosage are you taking? How long have you been on it. Is this the only drug? There is a new trial starting for those who have progressed on Crizotinib combining the two. I've just signed a consent for this Phase 1 trial so am very curious as to all of the side effects (and effectivenens). Please let me know.
Thanks, Ellen
Also, I just looked at that Phase 3 trial on their website (not in US) that compares Dacomitinib with a placebo. SERIOUSLY??? A PLACEBO? Please tell me I read this wrong as it seems highly unethical.

By momica
Reply 2859292
February 22, 2012 at 7:55 pm
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I am praying for u!

By decoy1616
Reply 2860134
February 23, 2012 at 7:33 am
Ellen, I'm on 45 mg/day, once a day, taken in the morning, two hours after & two hours before food (but I'm allowed to eat up to 500 calories with it). Congratulations on getting into the phase I trial.

My initial side effects were: moderate facial rash, intense diarrhea, dry mouth, and mouth sores. I'm now halfway through my second cycle. I'm on an antibiotic for my facial rash and I use an antibiotic cream, so my facial rash has gotten more bearable. Three weeks ago, I started acupuncture for the diarrhea, and it has helped immensely (my blood pressure has also dropped, a great side effect). My scalp, though, has become extremely itchy and I have terrible dandruff. Like the facial rash, I'm hoping the scalp problems will subside over time. I'm also losing my hair, but it hasn't gotten "patchy" yet. I already have a wig. I'm ready to get a short hair cut if need be. I've also started using Tom's of Maine mouthwash and that has helped my mouth sores.

Please let me know if you have any more specific side effect questions. So far, they seem very similar to Tarceva.

As far as the Phase 3 trial, it's true that they test with a placebo. We need to be extremely grateful to volunteers like JTMCP's husband (see post above) who have agreed to help us by taking a risk and participating in the studies. I have heard that if the drug is shown to work well, they will end the phase 3 trial early and get all participants onto the drug. But, the FDA requires phase 3 testing versus a placebo, in order to help ensure the drug truly works.

By CraiginPA
Reply 2860204 · In reply to 2859286 by Lucca
February 23, 2012 at 7:59 am
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Studies usually let placebo participants switch to the real treatment once it's shown they have progression, so that might only mean a delay in getting the treatment of you get randomly assigned to the placebo group initially.

By JTMCP
Reply 2865707 · In reply to 2860134 by decoy1616
February 25, 2012 at 11:00 am
To be clear: My husband has been assigned randomly to either a group that takes tarceva or to one that takes the experimental drug. Because this is a double-blind study, he takes one of the active drugs (unknown) and a placebo pill. There is no group that takes no active drug in this Phase 3 study of PF-0029804 vs. erlotinib.

By Lucca
Reply 2871479
February 27, 2012 at 7:01 pm
Thanks for the reply. I am considering this Phase 1 trial (dose escalation and safety) of Dacomitinib and Crizotinib. Since I have other options (crizotinib only, alimta only, alimta and avastin) I am also seriously considering not doing this trial until the safety issues and efficacy questions are answered. I just progressed out of the phase 2 crizotinib trial, but my cancer is still small and indolent. (stage 4, but small and indolent). I am still in the decision phase (and, selfishly, what is in this for me that is better than standard treatment?). Hearing about your side effects helps.
Thanks,
Ellen

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Stefano:
Sorry that you feel progression. I may also be in the same boat, just waiting for next scan to clear the uncertainty. Below is the information I have for the trial on Dacomitinib:
1. Information: A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer http://clinicaltrials.gov/ct2/show/NCT01121575

2: Participants’ discussion: GRACE discussion started by Gail (Gn21):http://cancergrace.org/lung/topic/clinical-trial-nct01259089/page/2/.
The following links may provide different options:
Trial of BIBW 2992 (Afatinib) + Cetuximab http://clinicaltrials.gov/ct2/show/NCT01090011
GRACE discussion started by Jing: http://cancergrace.org/lung/topic/lets-share-the-experience-of-bibw-2992-ce tuximab/
http://cancergrace.org/lung/2012/06/09/ar-local-rx/
http://cancergrace.org/lung/2012/04/03/radiation-to-address-cells-with-resi stance-to-targeted-therapies/#comment-9624
Please take care, AB

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AB, Thank you, best of luck and spirit to us all.
Everyone, keeping in touch makes us stronger and educates overwhelmed oncologists.

Stefano

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It sounds like you've already gotten some good replies, so I'll just add one mention of a discussion that other's might not have yet:

http://cancergrace.org/lung/topic/acquired-resistance-to-egfr-tki/

Best hopes,

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