I missed your ASCO webinar but have gathered some exciting info about Selumetinib for KRAS mutations. I cannot find any info about a phase III clinical trial of Selumetinib and Docetaxel. Having had such good phase II results, one would imagine a phase III would be in the works. I am trying to find a way to get access to Selumetinib for my KRAS positive stage IV lung cancer patient brother and would appreciate your guidance.
Is there a transcript of your ASCO webinar somewhere?
Thank you for all you are doing.
Reply # - July 12, 2012, 10:52 AM
Hi Marian, I can't find any talk of the phase III trials starting yet.
this is what I think you're looking for
Below are the 2 parts of the post ASCO webinar however I did a search and neither mention selumetinib. Which is probably why Dr. West just posted the blog/post a couple of days ago I've linked to above.
Edited to say Marian, don't hesitate to ask more questions. The doctors aren't scanning the site so much so if you have a question you wish to ask specifically to our doctors just say so and Jim or I will shoot them an email.
Reply # - July 12, 2012, 06:06 PM
I can help clarify. The transcript will be out in a few weeks, but it's not out yet.
There is definitely major interest in a larger, phase III trial based on the encouraging data in the phase II trial presented at ASCO. At the same time, the hospitalization rate with the combination was quite high, so we need to learn more about the tolerability of the combination.
It usually takes at least 6-12 months to get a big trial off the ground, even if it's a priority to the company and the world. It's very expensive and requires hundreds of participating sites, and a sponsor company needs to invest so much that they want to ensure they develop it as intelligently as possible, rather than rush in, spend literally hundreds of millions on a phase III trial, and end up doing it not quite right.
Reply # - July 13, 2012, 12:10 PM
Thank you very much for your responses. We are now looking into maybe enrolling my brother in an NIH study of Selumetinib with Tarceva, or a Northwestern study of ARQ197 with either Tarceva or Docetaxel. We feel we are in a casino and gambling with his life in trying to decide which drug or study to pick!
My brother's oncologist had never heard of either investigational drug and cannot help us. He just says he will support whatever choice we make! Whatever we choose it will be the 3rd chemo regimen. He responded well to both of the first two regimens but developed an anal fistula (which some blame on Avastin) and that really knocked the wind out of him. The oncologist took him off chemo for 4 months and basically ignored him until his cancer started to attack very aggressively suddenly last month. Now it is popping up and growing like crazy.
I wonder if there is any general information and opinion you might be able to share about the above 2 studies. His onc wants to put him on Docetaxel but that would be chemo #3 and would then disqualify him from the studies. So for now he is back on Alimta (1 round) without the Avastin. The Alimta/Avastin had worked very well on all the lesions except those on the bones.
Reply # - July 13, 2012, 12:44 PM
You can read some general information about ARQ197, also known as tivantinib, by searching the site using those terms. The earlier work was a phase II study of Tarceva (erlotinib) with or without ARQ197. Beyond that, I don't think we have any additional general information to offer. These studies that you mention simply haven't been done yet, so we don't know what they will show.
Reply # - July 21, 2012, 04:01 AM
Does participation in an tivantinib (ARQ197) or selumetinib make one ineligible to participate in a trial of the other subsequently? (I ask this not for my sake, but because the question might be relevant to those trying to decide on participating in those.)
Reply # - July 21, 2012, 10:12 AM
Not necessarily, and probably unlikely. It really depends on the individual trial in question, as each has its own list of eligibility criteria that are developed by the sponsor. It's definitely typical for trials intended for Tarceva (erlotinib)-naive patients to exclude patients who have received any EGFR inhibitor therapy, but since tivantinib (ARQ197) is a c-MET inhibitor and selumetinib is a MEK inhibitor, I wouldn't presume that there would be any issue with eligibility except that these trials often specify a maximal number of prior treatments that a person can have received.