Phase 1 trials : Hi, I have advanced ovarian... - My Ovacome

My Ovacome

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Phase 1 trials

Pippasandy profile image
23 Replies

Hi, I have advanced ovarian cancer and have became platinum resistant. I was given Niraparib but it didn’t work. I am now facing Paclitaxel and dread the prospect. I am considering and being considered for a phase 1 trial and wondered if anyone has any thoughts on how beneficial a phase 1 trial would be for me.

Thank you for any opinions, thoughts and experiences.

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Pippasandy profile image
Pippasandy
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23 Replies
Neona profile image
Neona

I have been on a phase one trial for 3 years and 8 months so far. It has kept me alive when I had no hope. Monitored every 2 weeks, care is excellent. Highly recommend.

Pippasandy profile image
Pippasandy in reply to Neona

Hi,Neona, Thank you so much for your reply and encouragement. I am very tempted to go ahead and your words have helped. Many regards and best wishes.

Golfjazz profile image
Golfjazz in reply to Neona

Hi Neona, I’m going thru the same thing with refractory On letrozole right now but ca 125 rising.

Tell me about this trial you are on. As to treatment, side effects, ect

I’m in California and wondering if there is the same trial here.

Neona profile image
Neona in reply to Golfjazz

It is an ATR inhibitor. Trial has finished but there are others. I have clear cell so you will need advice for the type of ovarian cancer that you have. Think it is to do with having Arid1a mutation and PiK3

Montydon profile image
Montydon

Hi PippasandyI am stage 4 Low grade OC and have been on the FRAME phase 1 trial at the Royal Marsden for 12 months. It has been a bit of a rollercoaster with side effects to deal with but overall like your previous reply it has reduced my tumours and is keeping me alive!The attention to detail is first class and I feel very ‘cared for’. Everyone has different experiences but when your options are limited it’s worth a gamble .

Hope this helps

Realistic profile image
Realistic

I have serious stage 3 Ovarian cancer the chemo treatment of carbo/Taxol 2 years ago seemed to have kept me in remission since. But if anything started up again ld jump at the chance of a trial and these lovely ladies storys l think will fill youwith positivity lm sure. I know this may seem a stupid question but what causes a person to become platinum resistant have seen this quite a few times on posts. Good luck with what you decide but if it was me l'd have the trial if offered. Sending love & hugs to us all SheilaFxxx

Terra1 profile image
Terra1 in reply to Realistic

What good question Sheila - it got me wondering too. If I've understood correctly most of us with OC become platinum resistant eventually as the cancer adapts to chemo treatments & they become ineffective : "ovarian cancer has poor survival rates due to a combination of diagnosis at advanced disease stages and disease recurrence as a result of platinum chemotherapy resistance. High-grade serous ovarian cancer (HGSOC), the most common ovarian cancer subtype, is conventionally treated with surgery and paclitaxel/carboplatin combination chemotherapy. Initial response rates are 60–80%, but eventually the majority of patients become platinum-resistant with subsequent relapses".

There seem to be many treatments & targeted therapies and many members know far more than me - but your oncologist will know your background and what is available & most suitable for you, PippaSandy. As the other ladies have said already taking opportunities for trailblazing could have terrific results both physically and mentally.

That Pfizer & Moderna are mRNA C-19 vaccines and there is so much development in this area and mRNA is mentioned in context of platinum resistance, may be a basis for further questions & optimism? Good Luck - so sorry niraparib alone not working.

Realistic profile image
Realistic in reply to Terra1

Thank you, some times l have so many questions but you've certainly made it clearerSome people don't want to know but l do so hopefully lm prepared for the next leg of treatment. Bless you and hope that all goes well for you love SheilaFxxx

rosebine profile image
rosebine

What is involved in a Phase 1 trial?

Worsuz profile image
Worsuz in reply to rosebine

Hi - I’d also be keen to understand what is meant by a phase 1 trial. My wife is currently on etopiside maintenance after successfully getting the disease under control on the Rotterdam regime. Etopiside side effects are pretty challenging

Bellabella7 profile image
Bellabella7 in reply to Worsuz

My understanding is that there are 3 phases of trials… phase 1 is a new and untested ‘product’.. so the medical profession are starting afresh with medicine which has no known history. But obviously they hope/believe that this may work. Stage 2 trials are medicines which have had some positive results but are being moderated and closely monitored to become more effective. Stage 3 are then the medicines which have had positive results on whatever it is they are targeting and awaiting approval prior to general release. This is super simplified! There are many many hoops a medicine has to go through with trackable results prior to general release. Hope that helps a tiny bit x

Worsuz profile image
Worsuz in reply to Bellabella7

Thank you. That does help. 👍🏻

Newbie_2020 profile image
Newbie_2020 in reply to rosebine

In Phase 1 Trials, the drug hasn't been tested/used outside the Labs. The aim of Phase 1 Trials is to evaluate the toxicity of the new drug and to find the highest dose that can be given safely without causing severe side effects.

Not always, all phase 1 trials are “first in human” since a drug is normally tested in more than one phase 1 study. In other words, the “first in human” concept refers to the very first trial in which a drug is evaluated in patients.

In all phase 1 trials, they start with a low dose of the drug and they keep increasing it, referred to as dose escalation, until they reach the highest tolerated dose. This is usually done across a small cohort of 25-35 patients.

The results from phase 1 trials define the best dosing scheme to be used in later phase 2 and 3 trials.

soyoon profile image
soyoon

HI, I am in phase1/2 trial, which has shown efficacy in reducing my tumor. I chose this trial in part because I knew that I will be given the drug and not the placebo. In phase 1 trial, they don't include placebo, so you know you are getting the drug. The goal of Phase 1 trial is to test for the safety of the drug by giving the drug in increasing amounts (to different cohort of people), so that they can determine the maximum tolerable dose for the drug. Of course, since it is the trial, they monitor your side effects very closely. From phase 2, they begin testing efficacy in small cohort but again without placebo, which is the case for my phase 1/2 trial. Phase 3 is the real test in which hundreds of patients are tested with placebo group. One it is shown to be effective, they can go for FDA (US) approval.

There are many trials for OC at least in the US. Current focus of many trials is to mobilize your own immune cells to combat the cancer rather than simply giving drug that kills off rapidly dividing tumor cells (along with other normal cells in our body). One type is to use an antibody that targets a protein on your tumor that is also linked to a chemo drug, such as taxol. A trial of this type, Mirvetuximab Soravtansine in phase 3 has been reported to be effective in its mid-report. The other type is to bring your own immune cells to your tumor using an antibody to a tumor protein while engaging your own immune cells. This type of trial is what I am participating in. My hope is that when you engage your own immune cells, it may be less likely that you develop resistance, like many OC patients do to carboplatin. If you ask why our own immune cells do not attack tumors, scientists have discovered that tumors are very clever so that they have a way to block your own immune cells to kill them off.

I hope this helps.

Lizzieanne profile image
Lizzieanne in reply to soyoon

Wow what fantastic information from the US thank you

Pippasandy profile image
Pippasandy

Thank you all so much. This is the first time I have posted and really glad to be part of this supportive group. I have not actually been offered the trial yet just having had the the first video meeting. Because the first phase trial is all about safety and dosage of the drug I was not sure whether it wouldbe useful to me. Since Niraparib did not work for me I have been 4 months without any treatment and Paclitaxol looms. The replies have been helpful and the trial team have confirmed that a biopsy is possible from the lymphnode on my clavicle.Next video meeting on Thursday.

Thank you again!

Gemmyw profile image
Gemmyw

Which trial Pippasandy? My onc has been reaching out to get me on one (stage 4 b, platinum resistant, high grade) without success.

SopSinger profile image
SopSinger

No-one can actually predict whether a phase 1 trial will be successful or not - it is, by definition, experimental. Phase 1 is the first use of the drug in humans (after animal testing) and seeks to establish what dose is safe to use. Phase 2 is an initial look at efficacy (usually varying doses and/or varying combinations of drugs - cancer trials don't use placebo, because it is unethical to withhold treatment, so usually phase 2 is new agent plus standard treatment, compared with standard treatment). Phase 3 uses larger numbers of patients and investigates more detailed safety/toxicity information and better information about efficacy because of the larger numbers.

January-2016-UK profile image
January-2016-UK

I’ve been on phase 1,2 and 3 trials. I always look up the drug(s) I’ll be given on clinicaltrials.gov for trials in any country because even with a Phase 1 Trial, I’ve found that it has been trialled on other cancers perhaps together with another drug. So you won’t feel so nervous that you might be the first patient or thereabouts to take the drug. The care on trials is really good.

I would also ask the trial team why they consider this particular trial might be a good fit for you. It may be they’ve had promising results in the lab for your type of ovarian cancer.

Good luck!

Pippasandy profile image
Pippasandy

Great to hear from you all. I have just started the process so don't know if I'll get on one yet hence I don't know which trial may be offered to me if any.

Best wishes!

Ruebacelle profile image
Ruebacelle

Hi. What kind of trial under whose auspices and what is the objective? In general I think trials are the way to go as the patients get first dibs on new approaches. On the other hand taxol is very good at reducing and then holding the line.Once you have done the research you will know better what to do. Hugs from paris. Meanwhile am jealous they won't recommend trials for me as I've had 5 lines.

Pippasandy profile image
Pippasandy in reply to Ruebacelle

Thank you for your message. I have not been offered the trial just in early discussion about possible trials. Best regards

Lizzieanne profile image
Lizzieanne

Great posts so much information

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