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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).

🤞🤞🤞

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

I have been approved to participate in the trial!

Treatment schedule 

28-day cycle

2 weeks on, 2 weeks off

Treatment on Days 1 & 8

Cycle 1

Pre-Day 1: Blood \ Urine \ ECG \ Dr 

Day 1: Blood + Dr + Ondansetron pre-med (1/2 hour) + Treatment (1 hour infusion) + Observation (1-hour) + ECG (in chair)

Days 2-6: off

Day 7: Pre-Day 8 tests - blood, Dr 

Day 8: Ondansetron pre-med (1/2 hour) + Treatment (1 hour infusion) [no ECG, no observation]

Days 9-27: off 

Pre-treatment med: Ondansetron (anti-nausea med)

Participant Sun Exposure Diary: A daily diary is to be completed indicating that sunscreen is applied and reapplied, indoors and outside, total sun exposure each day (approximate) and any other uncomfortable skin or eye side effects. The nurse also asked me to note the time when Ondansetron is taken each treatment day. 

Other on-treatment tests/schedule

CT: every 8 weeks

ECG: every pre-Day 1 + one hour after each Day 1 infusion

Eye exam: every 8 weeks

Biopsy: when trial ends/progression

Cycle 1 complete!! But not without some issues. 

Side Effects

I did not experience any nausea or additional fatigue. 

A potential side effect is hand-foot syndrome.

Another potential side effect is mouth sores. 

Eye sun sensitivity is another concern while on this drug. Sunglasses are provided and there are eye exams every 2 cycles. 

This drug makes me extremely sun sensitive and even though I donned all the UV protection garb, I managed to get sunburned after my first treatment!

Bottom lip, swelling with blisters…ouch!! I am currently trying to heal my lip and found that Eucerin Aquaphor Lip Repair is providing relief and, hopefully, healing. I tried some other lip treatments but they just didn't cut it for me. 

I am now thinking of a way to ensure I have extra protection for my lips in addition to the SPF lip balm. I think if I wear a mask under the hat mask when I am going to be out in direct sunlight for a period of time that should do the trick!

My left hand had some redness across the knuckles. My right hand was sunburned on the top of the hand with redness and some swelling. As well, 4 of my fingernail beds have turned dark. I think the hand burn was a result of driving (steering wheel) even though I had applied sunscreen and was wearing the UV gloves. The Dr prescribed a cortisone treatment for the hands. 

For my hands, while driving, I may resort to wearing a light pair of winter gloves over my UV gloves. 

The Dr had to contact the trial sponsor to inform them of my issues. She indicated (warned me) that the sponsor may want to reduce the dose for Day 8 and moving forward as a result of my reaction. Fortunately, the dose remained the same for Day 8 and I have extra incentive to ensure I am doubling up my protection so I do not find myself in this position again. 

Since I had these side effects, the Dr has scheduled a telephone appointment in a week to see how I'm healing and if there is anything new.

I am again travelling to Toronto from London and staying at the Princess Margaret Lodge from Monday to Thursday each treatment week. 

I am now off treatment for two weeks. YAY!!

Notes

As someone who has never had an issue with sun exposure - I tan very easily - this new way of protecting myself has been an experience! I am slowly getting used to having to take the time to ensure I am sunscreened and wearing my protective gear before I go outside. 

The last time I had hand-foot syndrome and mouth sores was after my third treatment of another drug...so, I am waiting to reach and hopefully surpass that milestone without any issues while receiving this drug.

From past experience with hand-foot syndrome, I am applying Eucerin Complete Repair Plus moisturizing lotion with 10% Urea on both my hands and feet when I go to bed. There are many other suggestions on this site if you want to explore potential precautions/remedies for this syndrome.

I am doing a salt water rinse before bed each evening to try to ward off mouth sores. If I do happen to get mouth sores, I know the prescription magic mouthwash will take care of it. 

For the sunburn on my hands, the Dr prescribed Betaderm ointment (.05%). Directions indicate to apply twice a day for seven days. So far, this ointment seems to be doing the trick. 

For the sunburn on my bottom lip (with blisters), I am applying Eucerin Aquaphor Lip Repair very frequently throughout the day. This product provides some cooling when applied, moisture for awhile, and it seems to have healing properties for my blisters and sensitive lip where skin now has to be renewed. I have to be careful what I eat so that I don't irritate my lips (i.e., no acidic or salty foods, etc.). This is not an SPF product, so I still have to apply SPF lip balm when I go outside to ensure I have sun protection. It is difficult to find an SPF product that does not irritate my sore lips (perfumes, flavourings). I usually use Blistex products for my lips and found Blistex Ultra Protection with SPF 30. This lip balm feels good on application and I do not get that tingly ouch when I apply it to my sore lips.