2nd generation drug trials for non responding Xalkori - 1261284

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kronk
2nd generation drug trials for non responding Xalkori - 1261284

Dr West et al, my wife last year diagnosed w stage IV adenocarcinoma w ALK mutation. 3 tumours and pleural inclusion suggested treatment w Xalkori at MSK. Early good response however response rate failure this November with tumour progression. Unusual situation is that we are posted to embassy school(teachers) in Moscow Russia and we are currently augmenting xalkori with alima+carboplatin for a 3 to 4 week cycle until we can find a trial (our onc suggest the new chugai drug alectinib) that will take my wife. My contract will finish in June and we would not like to wait until then to join one. Question becomes where can we find a list of chugai trials US and intl or ALK second generation trials and how easy would it be to switch to second location as we would have to move to a job back in North America. Wishing all Health and Hope in the New Year . Gregg and Saule

catdander
Reply To: 2nd generation drug trials for non responding Xalkori

Hello kronk, Welcome to Grace. I hope your wife is feeling alright though I'd imagine she at least has some rough days on 2 treatments.
The website clinicaltrials.org has trials listed though close it's not always up to date. Following is a link to results of a search for moscow | nsclc | Russian Federation. http://clinicaltrials.gov/ct2/results?term=moscow&recr=&rslt=&type=&cond...
This should at least get you started and give you an idea of where this type of research is happening and who's doing it.
As far as moving locations I hope you can. I'll ask a doctor to reply.

Hopes for a Happy New Year,
Janine

Dr West
Reply To: 2nd generation drug trials for non responding Xalkori

I'm sorry for these complications. It may be most helpful to try to reach someone at Chugai involved with the clinical trials program there. Your situation may require an individualized answer and interactions with someone within the company. I don't know of anyplace where information about the specific locations of trials sites and contact information is made available, with the clinicaltrials.gov website probably being a leading bet for potentially helpful websites, searching for alectinib or CH5424802 (its designation before alectinib)

Good luck.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Medical Oncologist
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

nandaalves
Reply To: 2nd generation drug trials for non responding Xalkori

Hello, my name is Fernanda, I'm a doctor and I live in Brazil. My mother carries NSCLC ALK MUTATION and recently we discovered that, after 7 months of treatment, she failed the treatment with Crizotinib. I looked for and I have seen that Brazil still has no provision for inclusion in trials evaluating the 2nd generation drugs for non responding Xalkori. How do I proceed for help my mother to a chance to receive one of these medications through ongoing studies?

Thank you,
Fernanda Alves.

catdander
Reply To: 2nd generation drug trials for non responding Xalkori

The drug, LDK378 is still being studied and in some instances has been given on a compassionate use basis. Although Novartis is only studying it as a first line treatment in Brazil it would be worth following along the lines of Dr. West's suggestion below in Brazil. Also note the thread from which the quote is linked is a very good place to find the leading edge info on ALK. Alimta is also thought to give good response in those with ALK.

When asked a similar question Dr. West suggested, "LDK378 is currently available in some places on a compassionate use basis. If you can reach someone in Australia from Novartis, they might be able to tell you locations. If I had to guess, one site in Australia that I’d suspect might have it available is Peter MacCallum Cancer Center, since Dr. Ben Solomon there has been a global leader in clinical trials with crizotinib and other ALK inhibitors". http://cancergrace.org/topic/alk-or-ros1-nsclc-patient-group/page/20/#po...

I hope this helps,
Janine

Dr West
Reply To: 2nd generation drug trials for non responding Xalkori

I'm sorry that I really don't know how to access one of these investigational agents outside of the United States. I imagine that and the opportunities depend on the specific rules and regulations of various countries, though I think that the larger academic centers would be my leading that for the most fruitful contact point. As Janine mentioned, Alimta (pemetrexed) is also a standard chemotherapy options that can be very helpful in many patients with an ALK rearrangement.

I do expect that LDK378, now christened ceritinib, is likely to be approved and commercially available at least in the US sometime in the next 6 months or so, though I don't have any specific knowledge of a timeline. I don't know when it will become available in other parts of the world, but there is reason to be hopeful that it and potentially other second generation ALK inhibitors will become commercially available in many parts of the world relatively soon. I also expect to see a growing number of clinical trials with such agents available globally, so there may be an opportunity to seek one out, whether within or outside of Brazil, at some point in the not too distant future, even if was not available now.

Finally, I would just note that some patients who demonstrated progression on a targeted therapy may continue to do well without any treatment change, or with a local treatment for a single spot of progression, if their disease progression is very limited.

Good luck.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Medical Oncologist
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education

shart215
Reply To: 2nd generation drug trials for non responding Xalkori

My mother was diagnosed with adenocarcinoma with subtle squamous in pleural lining. she has the ALK mutation.She was put on Xalkori but it was stopped because CAT scan showed possible pneumanitis and increased pleural effusion. Was not eligible for Ariad study. Developed afib and blood clots in lungs. Not eligible for Ro5424802 study at MSK.Had two cycles of pemexetred. CAT scan showed tumor had grown, increased fluid pressure on heart. Started ceritinib one week ago.
Questions: 1. Has ceritinib been effective in patients where crizotinib did not work and 2. how soon could we see positive results from ceritinib?
Please forgive me if I misused any medical terms.
thank you
Suzanne

Dr West
Reply To: 2nd generation drug trials for non responding Xalkori

Suzanne,

We simply don't know if ceritinib works well in patients who are immediately (also sometimes referred to as primarily) resistant to crizotinib will respond as well to ceritinib as the broader population, in whom ceritinib is associated with a response rate of around 60%. It's reasonable to think that the response rate may well be lower in patients who don't respond at all to crizotinib, and that's what I've seen in a few of my own patients and heard from others involved in early trials with the second generation ALK inhibitors. In some of those patients, the progression may be because the ALK-positive result is a "false positive", since the test is actually pretty fallible.

On the other hand, if crizotinib was discontinued due to an adverse reaction rather than progression (as the increased pleural effusion could be part of an inflammatory response along with a lung infiltrate associated with pneumonitis), then it wouldn't necessarily predict for lower probability of response to crizotinib.

Good luck.

-Dr. West

+++++++++++++++++++++++++
Dr. Howard (Jack) West
Medical Oncologist
City of Hope Cancer Center
Duarte, CA

Founder & President
Global Resource for Advancing
Cancer Education