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Novartis

Posted by on Jan. 22, 2009 at 10:49 AM
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(Update: June 26, 2008) We have received word from Leslie Fields of Novartis that the protocol summary will be available for release sometime in mid-July, and that trials are expected to be launched in August at six of the nine sites. As soon as they are ready to recruit patients, she will send me the contact information and we will post it prominently on this website.

(April 23, 2008) I received a call today from Leslie Fields, the Patient Advocate from Novartis, who is working to coordinate the opening of the study for PKC412 (Midostaurin). I have some details, although not all of them, but I wanted to share what I know for those of you who are anxiously waiting for information. She did not have the inclusion and exclusion criteria yet.

  1. This will be an open label study, single-arm phase, so all patients will get the drug, and no patient will get a placebo.
  2. There will be a year of recruitment, starting in August in the United States, and a year "on study."
  3. For those patients that have good results on the drug, therapy will be continued for compassionate use.
  4. There will be inclusion and exclusion criteria, but again, I do not have them yet.
  5. The current sites in the US will be at UCLA, the Oregon Science Center, and the University of Colorado.
  6. This will be a global trial, and the other sites that will be involved will be: France, Germany, Italy, Austria, Canada, Australia, and the UK.

Ms. Fields does not yet have the details about costs involved for the patient, and she did not know yet if transportation to the centers could be covered. Those details will be available later.

I will be in touch with Ms. Fields, and we will work together on making this information available to all patients with aggressive mastocytosis.

by on Jan. 22, 2009 at 10:49 AM
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bellasmom870
by on Jan. 22, 2009 at 10:50 AM

I just thought this was interesting. I never hear of to many meds for masto.

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