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Post by Tony Crispino on Jun 19, 2014 20:44:49 GMT -8
This is interesting. Takeda is the Japanese firm that makes the drug Orteronel otherwise known as TAK700. I am currently on panel for this research. www.takeda.com/news/2014/20140619_6615.htmlI don't have anything as yet to say about S1216 trial at SWOG (Edited: please read below). In the article Takeda stated " After careful consideration of the data from these trials, the company has determined that the drug has not demonstrated a clinical profile sufficient to move forward in mCRPC, given the availability of other therapies." This does not say it isn't effective, but rather that it indicates that it isn't clinically better than other options that are already available. I'll be interested in how this works out.
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Post by Tony Crispino on Jun 27, 2014 14:02:00 GMT -8
Clinical Trial S1216 is still alive. TAK700 for castration sensitive PCa is continuing. Takeda is still supporting this research. More to follow.
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Post by Carolyn Spivak on Sept 11, 2014 13:05:32 GMT -8
Hey Tony,
My husband just got offered this trial - the surviving piece of it. Does this still make sense if they're not going to be marketing it? Can you point to where there was more (to follow per your previous post)? Just learning about this .....
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Post by Tony Crispino on Sept 11, 2014 15:08:31 GMT -8
Hi Carolyn, As of right now, Takeda is keeping this trial alive. The key difference between this trial and the two trials that did not show overall survival benefits is that the S1216 trial is for men initially diagnosed with metastatic hormonally sensitive PC (mHSPC) instead of hormonally refractory disease (mCRPC). Should this trial show the desired benefits then Takeda may in fact release the drug.
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Post by lupronjim on Sept 14, 2014 19:33:58 GMT -8
As I told Sonny when he was considering this trial, you can't lose as either arm gives you a treatment drug as opposed to a placebo.
Obviously if you get into the TAK700 arm you are luckier since you are getting early access to a potentially beneficial drug not generally available until trial results are known.
LupronJim
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Post by Tony Crispino on Sept 15, 2014 19:06:25 GMT -8
Jim, With a caution I say the purpose of a clinical trial is not as a treatment but rather to answer a question. That stated trials are always best when the control arm is the standard of care. S1216 compared the standard of care to a new AR drug with an active known testosterone ablation therapy. The patient gets a solid fight either way. I would have felt a lot better in Sonny's case if he had a better early response and achieved a remission but it wasn't the case. So it is he has new options and I like his team.
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Post by cspivak on Sept 17, 2014 19:10:20 GMT -8
Hey Tony &Jim,
My husband just signed consent for this trial today. We'll see which arm he ends up in (assuming nothing weird turns up with insurance and the trial's extra scans). At least he made an informed decision and is feeling comfortable about it.
Thanks for the good info!
Carolyn
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