English Community

Well folks, here I go again!! A new trial!!

CX-5461

Phase 1 study to find the right dose of CX-5461 and to look at what effects CX-5461 have in patients with solid tumours with BRCA2 and/or PARB2 mutations

Cancers included in the study: pancreatic, ovarian, prostate and breast cancer

First, although I do not have one of the two mutations identified in the title, I do have a mutation, NBN, that is included in the main group of this study. A special shout out to the Fellow who was working the day I went in to explore trials!! I was already assigned this trial, but he recognized the mutation and went to confirm that it was, indeed, a mutation being explored for this trial. I have to say, it provided some relief to know that I had two specific things for this trial.

This is a phase 1B study so it is still in the early phase and does not mean the drug will target the mutation but at least it is being explored and may help those that come behind me. On a more positive note - and with "hope" - the drug may be exactly what I need!! 

I am just moving through the screening process now and will continue to journal my experience.

@GloHo  Wonderful news!  Keep us posted!

CX-5461

Phase 1 study to find the right dose of CX-5461 and to look at what effects CX-5461 have in patients with solid tumours with BRCA2 and/or PARB2 mutations

Pre-screening process 

Meet with the Dr to review trial recommendation.

Meet with the trial coordinator to discuss tiral requirements and sign documents to begin the trial screening process. 

There is a 28-day (or less) window to complete all required tests to determine if you meet the criteria for participation.

Screening tests

Blood

CT 

ECG 

Heart test (MUGA) - a small amount of radioactive tracer injected

Eye exam (external eye clinic - costs covered by trial)

Biopsy 

Results

Heart test: Borderline abnormal 

I'm sure the Dr will discuss these results with me. I am not too concerned as the ECG done during this procedure was fine. I did fall asleep, twice!, during the test. That may have contributed to a couple of blips during the test?😂 In any event, they did not ask me to return for further testing which, according to my coordinator, is a good thing.

Biopsy: I opted for local freezing only, no sedative. I had 7 cores taken - one for clinical and six for the trial. Some of the trial cores may be for the three genetics studies I am participating in! One core will be sent to pathology and will reveal any genetic changes. The Dr has also indicated that she is going to test my FRa status from this tissue to see if I qualify for Elahere compassionate use.

The ultrasound monitor broke down during the procedure and they had to switch it out.

I did not experience any pain following the procedure and there is only a small bruise at the puncture site. 

CX-5461 known side effects

Usual - fatigue, nausea, etc. 

Eye - photosensitivity to UV rays

Skin - whole body photosensitivity to UV rays

As you may have noticed, sun sensitivity is the main side effect. 

This means that I will have to avoid direct sunlight and be covered from head to toe, LITERALLY, when I am out and about. 

It's funny…tell me you're going to inject all kinds of poison into me and I don't blink. But tell me I have to avoid the sun and I hesitate. It will certainly be interesting and challenging!

The trial provides 

Sunglasses (wear over)

Hat

Jacket or hoodie

Gloves 

Sunscreen/lip balm (replenished each cycle)

UV-rated clothing

I decided to look for protective clothing. Much to my surprise, most sports store sell this clothing for runners, swimmers, etc. I found some pants, on sale!, so picked up a few pair. I am now looking for some tops - not in many stores yet…will check in a couple of weeks. I was just at Winners for something else and found a couple of UV-rated tops there! I am also looking for swimwear (full coverage) - we have an aboveground pool that provides much relief during the hot summer months. You can, of course, order all this stuff online but I like to see/feel what I am getting.

My team

The trial team has been phenomenal! My emails (questions) are answered promptly and information regarding test requirements were provided in a clear, concise email. I feel like I am well-supported and can reach alternate contacts should the need arise. 

Reimbursement

The information package indicated the trial would reimburse travel and parking costs. I am an out-of-town patient so this is of interest to me!! However, when I asked my coordinator to follow up with them for specifics, she said they would pay $35. So now I have lots of questions about what that means. I plan on sending a little note with my first reimbursement submission explaining what costs are associated for my participation in this trial as an out-of-town patient. We'll see what comes of that. Some trials do not cover any costs, so even a little something is welcome. I don't know how they arrive at the amount - that would not even cover parking or taxi/uber if you were local. 

Vaccines

While I was on my chemo holiday, I decided to get caught up with all of my health vaccines (COVID, flu, shingles #1). I have to go back for shingles shot #2 within 6 months which will be during the course of this trial. I asked about this and I will be allowed to get it but I will have to coordinate it according to my treatment schedule. Makes sense and am thankful that I will finally be able to complete my shingles vaccine. 

Next steps

Next Tuesday I have pre-treatment blood/urine/ECG tests and an appointment with the Dr. We will review my tests results at that time and they will advise if I meet the criteria to participate in the trial. 

In preparation for an okay to move forward on this trial, there is a chemo chair already reserved for next Wednesday (Day 1) and the following Wednesday (Day 8).

🤞🤞🤞