› Forums › General Melanoma Community › GSK Phase III BRAF/MEK Combo Trial now Recruiting
- This topic has 9 replies, 3 voices, and was last updated 11 years, 11 months ago by
john partrick michael murphy.
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- September 30, 2012 at 4:04 am
http://clinicaltrials.gov/ct2/show/NCT01584648
The trial will randomize half the patients to the combo. The other half will get only the BRAF inhibitor. I have been on a Phase I/II trial of these two drugs for almost a year-and-a-half (getting both drugs), and have done very well. Also, very good interim results were reported at the last ASCO conference. I think that anyone who can qualify should seriously consider this trial.
Best wishes,
Harry
http://clinicaltrials.gov/ct2/show/NCT01584648
The trial will randomize half the patients to the combo. The other half will get only the BRAF inhibitor. I have been on a Phase I/II trial of these two drugs for almost a year-and-a-half (getting both drugs), and have done very well. Also, very good interim results were reported at the last ASCO conference. I think that anyone who can qualify should seriously consider this trial.
Best wishes,
Harry
- Replies
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- September 30, 2012 at 5:45 pm
This is very frustrating to read that this trial will not be completed until 2015, then analysis, then petition for FDA approval. Many people will die waiting for these 2 drugs in combo to be approved.
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- September 30, 2012 at 9:25 pm
GSK has already submitted requests to the FDA to have both drugs approved for single agent use:
The approvals could come later this year or early 2013. It's conceivable that oncologists could then prescribe them in combo, but the drugs in combo will probably not be approved by insurance or Medicare until the Phase III results are in.
Sometimes trials are ended before the planned date when early results are overwhelming one way or the other. So government approval for the combo could potentially come sooner.
Best wishes,
Harry
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- September 30, 2012 at 9:25 pm
GSK has already submitted requests to the FDA to have both drugs approved for single agent use:
The approvals could come later this year or early 2013. It's conceivable that oncologists could then prescribe them in combo, but the drugs in combo will probably not be approved by insurance or Medicare until the Phase III results are in.
Sometimes trials are ended before the planned date when early results are overwhelming one way or the other. So government approval for the combo could potentially come sooner.
Best wishes,
Harry
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- September 30, 2012 at 9:25 pm
GSK has already submitted requests to the FDA to have both drugs approved for single agent use:
The approvals could come later this year or early 2013. It's conceivable that oncologists could then prescribe them in combo, but the drugs in combo will probably not be approved by insurance or Medicare until the Phase III results are in.
Sometimes trials are ended before the planned date when early results are overwhelming one way or the other. So government approval for the combo could potentially come sooner.
Best wishes,
Harry
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- October 3, 2012 at 1:28 pm
Harry is right! I am in month 22 of this trial and it is working well for me and the few cohorts I know. I was spiraling down fast, then they let me in and the next thing I knew I felt OK, and a short while later, I felt normal again.All we do is take the Smith and Wesson pills they give us for free. Those guys go in there and shoot up the cancers big time. My brother has three post-doc degrees in experimental oncology and he said to stay in this fight we need three things: courage to fight it, and from this comes hope, and from this comes strength.
If you haven’t had your genome checked your oncologist isn’t practicing oncology…You should explain this to him or her and get on with the fight. This is high excitement. This is the future. This is living, not dying.
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- October 3, 2012 at 1:28 pm
Harry is right! I am in month 22 of this trial and it is working well for me and the few cohorts I know. I was spiraling down fast, then they let me in and the next thing I knew I felt OK, and a short while later, I felt normal again.All we do is take the Smith and Wesson pills they give us for free. Those guys go in there and shoot up the cancers big time. My brother has three post-doc degrees in experimental oncology and he said to stay in this fight we need three things: courage to fight it, and from this comes hope, and from this comes strength.
If you haven’t had your genome checked your oncologist isn’t practicing oncology…You should explain this to him or her and get on with the fight. This is high excitement. This is the future. This is living, not dying.
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- October 3, 2012 at 1:28 pm
Harry is right! I am in month 22 of this trial and it is working well for me and the few cohorts I know. I was spiraling down fast, then they let me in and the next thing I knew I felt OK, and a short while later, I felt normal again.All we do is take the Smith and Wesson pills they give us for free. Those guys go in there and shoot up the cancers big time. My brother has three post-doc degrees in experimental oncology and he said to stay in this fight we need three things: courage to fight it, and from this comes hope, and from this comes strength.
If you haven’t had your genome checked your oncologist isn’t practicing oncology…You should explain this to him or her and get on with the fight. This is high excitement. This is the future. This is living, not dying.
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