Questions on administration
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Duke….I looked at it: https://clinicaltrials.gov/ct2/show/NCT02042443 and found the error in that cycle time should have been explained clearly. Guess you need to reach out personally to the PI or study center participant to receive clear explanation as to the “break” between cycle 1 and 2. Or, whether Trametinib is given until toxicity levels are reached.
Hugs,
MarionDid not go down that road. Even though the info on the trial said the James was supporting it, they had not approved it yet.
Duke
I’d read that to mean you’re on three weeks and off the next three – rinse & repeat. Did you look into it more or go down this path Duke?
DukeNukem wrote:The FoundationOne report came back with possible several clinical trials. Only one is convenient to me geographically. That one (NCT02042443) has an arm that involves trametinib but has other arms that do not. Obviously I am only interested in the one arm.“Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.” Does this mean I get 21 days off between, or, the dosages vary and I take a pill a day every day until whenever?
Do I have to be administered the trametinib at the test clinic? It is three hours away. It would be much more convenient to have it administered locally. Staying in a hotel for three weeks just to take one pill a day seems a bit ridiculous. I could see visits on days 1, 7, 14, and 21, maybe.
Since only one of the arms would seem to work for me, could I have my onc prescribe trametinib under a “hardship exception”?
Duke
Duke,
I think they watch trials very closely. I had EKGs done every day for a week, then once or twice a week, then every 2 weeks for 3 months. Plus tons of bloodwork. I hate to say it but my guess would be you need to be at the CRU that administers the trial.
One bright spot: if it’s pills, you will eventually hopefully only have to go there every 4 weeks. But that’s about 3 months in. And they MIGHT accept bloodwork from elsewhere during some of the mid term visits after the first few weeks.
Good luck!The FoundationOne report came back with possible several clinical trials. Only one is convenient to me geographically. That one (NCT02042443) has an arm that involves trametinib but has other arms that do not. Obviously I am only interested in the one arm.
“Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.” Does this mean I get 21 days off between, or, the dosages vary and I take a pill a day every day until whenever?
Do I have to be administered the trametinib at the test clinic? It is three hours away. It would be much more convenient to have it administered locally. Staying in a hotel for three weeks just to take one pill a day seems a bit ridiculous. I could see visits on days 1, 7, 14, and 21, maybe.
Since only one of the arms would seem to work for me, could I have my onc prescribe trametinib under a “hardship exception”?
Duke
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