A question about crossover for you guys familiar with trial design. What does "no crossover allowed"? No afinitor branch to cross over cabo, and vice versa, that's for sure. How about crossing over to the third, fourth...approved drugs after progression? I think it's normal in general practice?
That's way too optimistic. My crystal ball told me: if 6 vs 14, on 5/15/2015, events will be more than 70%, greater than preset 69%. or 5.5 v 15. If cutoff date is after June, pfs will be greater than everolimus' OS. If everolimus performs exactly as anticipated, trial will be called off by then.
Exactly. Now how good the PFS looks like depends on how everolimus outperform 5.5 months. If only 6 months, we are close to 12. That will be giant good. OS is another story, many good PFS data didn't translate into good OS, cabo included. It curbs progression, and mutation eventually revengefully lead to faster OS event.
From 2014_10_27 to 2015_04_13, after about half year, they finally update celestial. On 2014_12_02, you can say exaclty nothing to update. On 2015_04_13, you can say next to nothing. One "not yet recruiting" mexico city site was added, and 4 "recruiting" sites were "terminated"(not "Active, but not recruiting"). Nothing else!
It sounds so weird. Before 2014_10_27, you can see them update recruiting status every 10 days or so. What happened with celestial during this half year? In a money saving mode waiting for meteor good result so we can raise some funds to run full speed with celestial?
At least they should give a little bit more hints on METEOR events count with this PR. Fast track is a surprise and not a surprise. They can give it to anybody with merits. We are running a trial against 5.x months, not 2.x months. FDA should award us who got a much higher bar to jump over.
If 15 months and 20 months medians hold true, my voodoo crystal ball told me, more than 40% of first 375 patients have encountered OS events. It's sad, and I didn't believe my crystal ball told me so. With these numbers, OS data in the interim(or, whatever you call it) analysis might not be matured(btw, crystal ball also told me we will have final analysis on next Feb or around), but surely will give us some ideas.
It all depends how well the everolimus is doing over expectation. I tried 183 days for its median, and we are still very good against it. I don't think PFS is a problem.
I asked my crystal ball: IF everolimus' median PFS is 5 months and trigger had been reached on 4/1/2015, what do we expect from cabo? It tells me: 12.
disclaimer: my crystal simulation also assume: 1/1 to 4/1, random enrollment to 50% and started immediately to dose, 4/1 to 7/1, 50%.
As we are entering second quarter of 2015, everybody panic. Unless the company tells you how many events of the first 375 patients have happened, we will remain so indefinitely.
comparing to METEOR: 3.3 sites for 1 patients, 1 site for 3.17 patients. That's 10x difference. And meteor had to recruit around the world, not only in the states. Started at the same time. The same against-approved-drug setting. Meteor finished recruitment 5 months ago. NCI is perplexing.
I know you guys are eagerly waiting for METEOR result. But attacking each other won't help. Let's muse on something. A question for you guys: why does NCT01835158 need 494 study locations to recruit 150 patients? Or is it a normal way the gov agency doing their business? Let them compete with each other for funding? If so, why can't they recruit 150 patients in about 2 years? It's Sunitinib vs Cabo, no fear of placebo branch and it's free. Already 32(Active, not recruiting), 62(Terminated). Why's so slow?
FYI, sorafenib, sunitinib, axitinib, pazopanib and tivozanib are not antibodies. You can easily tell that from the names -nib. Ever heard of -mab? Of the approved drugs for RCC, only bevacizumab(avastin) is antibody. And it is for metastatic. So you can assume most of our patients didn't take antibody.
Somebody here claimed you were an ex-employee, I really doubt it.
I see either you are confused or try to mislead other people.
1&2.Yes, these patients were receiving some therapies(exception: Everolimus).
3. Since placebo can only last 2 months, I really doubt the randomization and dosing may take at least 4 weeks.
It's sad that Cabo is not a magic drug that can cure cancers, most of metastatic patients will die of RCC.
But, most importantly, METEOR is not going to test if cabo a magic cure so most patients will recover. None of the trials is testing that -- it's a sad but true statement. METEOR is going to test if Cabo can delay progression longer than Everolimus can do. That's why this test is NOT set up to fail.
It may not be appropriate, but let's say: It's like to test if you can run faster than one of other guys in forest, not to test if you can outrun a bear. Got it?
you play the market with your testicles? If male hormone is the key for success in investment, I bet Warren Buffett will move to a prison of rapists, not Omaha.