AMG199 Clinical Trial Information & Delayed Start Date

Monday afternoon (June 27th) we met with the Research Nurse, went over the trial more in depth, and signed consent forms.

Here is the basic info we have so far:

Christian will need a full CT Scan (chest abdomen pelvis) to use as a baseline for the trial.
She also has a brain MRI to insure no mets there (which would be a disqualifier if so I think). 
She also has several labs needing to be drawn for several other pre-trial tests. 
When she gets her port accessed for the scans, they will draw the labs then.
We will be checking the CEA & CA19-9 levels as well.

That is all for the pre-trial testing and labs.

Her clinical trial start date was originally set for Monday July 18th, pending the tests / scans don't cause an issue.
We got a call from Dr. Paluri today (Wednesday June 29th), and he said that the sponsor (Amgen) called him and said that her cohort would be delayed until August 1st. So that is her new tentative start date.

Not info we wanted, but it is out of our hands (Amgen makes all of these decisions).
I could say a lot more about us wanting to get this trial started sooner than later, but it doesn't really do any good as it is what it is, and out of our control. All we can do is pray that the cancer will just chill out for the next month until the trial can be started, regarding the timeframe here.
We just need to be alert to how she is feeling, and signs of jaundice.
It sounds like that is the main thing to watch out for in her current situation. 

Now, more info about the trial:

One cycle is 4 weeks. There are 4 treatments in a cycle. So she will have treatment every week.
Treatment is always on a Monday (unless we need to move it a day for holiday, vacation, etc).

Because this is a phase 1 drug, there are a lot of unknowns. There are no list of "side effects" that you can fully expect, because there are not many people that have taken this drug. There are a couple things that they have seen in the few patients currently on it that they shared with us. Mostly it is flu like symptoms for a day or two from CRS (Cytokine Release Syndrome), that can be managed with Tylenol or other basic medications. Everyone's body is different, and the purpose of this phase 1 trial is to establish dosage, and common side effects (all while hopefully helping advanced patients). For this reason, they want to monitor her very closely for the first 4 treatments (all of cycle 1).
This requires her to be admitted to the hospital for Cycle 1 treatments.
Here is what Cycle 1 would look like:

Cycle 1 Treatment 1: Admitted Monday, Treatment & Monitoring, Discharge Friday.
Cycle 1 Treatment 2: Admitted Monday, Treatment & Monitoring, Discharge Wednesday.
Cycle 1 Treatment 3: Admitted Monday, Treatment & Monitoring, Discharge Wednesday.
Cycle 1 Treatment 4: Admitted Monday, Treatment & Monitoring, Discharge Wednesday.

That first cycle will be the most involved. If everything goes well with that cycle, and she moves into cycle 2, it will be a little easier because there is no hospital admittance required for that. 
Here is what Cycle 2 would look like:

Cycle 2 Treatment 1: Go to Pod Monday, 60 minute infusion, 4hr monitor, go home.
Cycle 2 Treatment 2: Go to Pod Monday, 60 minute infusion, 4hr monitor, go home.
Cycle 2 Treatment 3: Go to Pod Monday, 60 minute infusion, 4hr monitor, go home.
Cycle 2 Treatment 4: Go to Pod Monday, 60 minute infusion, 4hr monitor, go home.

After Cycle 2 is complete, they will do a full CT Scan again (chest, abdomen, pelvis) and also check CEA & CA19-9.

That is pretty much all of the info worth sharing on this right now.
It was a lot, so that is why we did a post on it. 
She is probably going to do a video post after her scan results next week, before treatment.

Thanks to everyone for everything.