Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholang
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- This topic has 24 replies, 11 voices, and was last updated 6 years, 7 months ago by katrina.
August 8, 2014 at 1:37 am #83683
His diet is a low-phosphate diet, Marion: no nuts or peanut butter; no whole grain breads; no milk, yogurt, ice cream, hard cheeses; no chocolate; etc. Thank you for the contacts; I’ll contact them tomorrow! If he has to leave this study (and maybe he won’t), maybe NIH will accept him. Thank you so much!
Jean-MarieAugust 6, 2014 at 6:58 am #83682mbachiniModerator
NIH is still recruiting. I encourage you to contact them and seek more information at the numbers and link Marion provided above. I hope his levels mellow out and he will be able to continue with success….praying the pain and nausea diminish and go away!!!!
MelindaAugust 6, 2014 at 1:06 am #83681marionsModerator
jtaylor…..a phase II study drug given to a larger group of people to see if it is effective and to further evaluate its safety; side effects will be evaluated and it appears that certain changes can be made without impeding on the design study. Perhaps your husband will do better and can continue on this trial.
As far as I know, many people are applying to be included in the study Melinda has responded so well to and I don’t see any reason as to why you should not contact:
June Kryk, R.N. (301) 451-1929 firstname.lastname@example.org or
Steven A Rosenberg, M.D. (301) 496-4164 email@example.com
referencing the trial Melinda has responded so well to
Wondering, what were the specifics of the diet your husband had to adhere to?
Your nagging comments made me chuckle, dear Jean. But what is a loving wife to do?
MarionAugust 5, 2014 at 11:17 pm #83680
One of the side effects of this drug is that phosphate levels get too high. MD Anderson started the trial with my husband taking a drug to lower the phosphates as well as a low-phosphate diet. He ignored the diet for the first week, and his levels were twice what they should have been. They doubled the phosphate meds and he adhered to the diet, but although his levels dropped some, they didn’t drop enough. They are taking him off the study drug for a week; if he is then where he needs to be, they will restart him on the study drug but at only 80% of the original strength. Also, he felt pretty good the first week of the trial but this week feels bad in every way. More pain (they’ve increased his pain meds today); nausea for the first time since diagnosis (they prescribed a drug for that); and more fatigue. I wonder if he had observed the diet his first week if his phosphates wd have gotten as high; but no amount of nagging could keep him on diet. I’m feeling very discouraged that we’ll have a good outcome and think I should start looking for other trials to prepare for the worse, which will be in a month when he has his first scans.
Why isn’t NIH doing a lot more studies of the procedure Melissa had, given her tremendous success, does anyone know?July 19, 2014 at 4:46 pm #83679kris00jSpectator
Sending lots of prayers for good results with this new trial! Please keep us posted.July 19, 2014 at 4:01 am #83678mbachiniModerator
Sending lots of good wishes and prayers your way for great results on this trial!! Please keep us informed. …..MelindaJuly 18, 2014 at 5:40 am #83677gavinModerator
Thanks for the info guys. Hope that the trial goes well for your husband Jean and please let us know how it goes. My fingers are crossed for him.
GavinJuly 18, 2014 at 5:40 am #83676marionsModerator
MD Anderson has launched and is ready for accrual. Other institutions will follow soon. A patient friendly explanation of this trial will be on the website within the next few days.
MarionJuly 18, 2014 at 12:11 am #83675jscottMember
It looks like they are starting up this trial at many of the major cancer centers.
The page on clinicaltrials.gov has the other centers (although everybody currently shows not yet recruiting.)
Thanks so much for letting us know how things are going.
JasonJuly 17, 2014 at 11:38 pm #10318
My husband will begin this trial on July 23rd: http://clinicaltrialsfeeds.org/clinical-trials/show/NCT02150967 . He’s doing it thru MD Anderson; will keep you posted.
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