Help Finding Clinical Trials

In simple words, we gave a combination of drugs ( pelareorep+ atezolizumab and chemo) to mPDAC patients, which is one of the worst cancers, and 3/3 “safety run-in” patients showed about 50% reduction in their tumor sizes in just 4 months!This is great 🙂

Early days by Oncolytics Biotech and Roche.

Welcome, @askretka. Do you have pancreatic cancer? Are you looking into clinical trials?

Welcome, @askretka. Do you have pancreatic cancer? Are you looking into clinical trials?

Finding a clinical trial can be a daunting task requiring perseverance. Precision Medicine (molecular profiling by Next Generation Sequencing [NGS] and liquid biopsies) to reveal possible gene mutations driving the cancer helps in narrowing the focus for using Targeted Therapy directed at the mutation. Even with that info, searches can be daunting reading through the scope of the trial and the inclusion/exclusion criteria.

Besides clinicaltrials.org, PanCan.org has a search page and case managers you can call (877.272.6226, M-F, 7:00am-5:00pm PT) that work with staff at CancerCommons.org to do the time consuming work in narrowing down the list of potential trials. LetsWinPC.org partners with EmergingMed.com that also has a staff you can speak with to get more clarification of a specific trial. myTomorrows.com is another clinical trial finder service and the staff takes it a step further- they will help with the enrollment process making the phone calls to principal investigator/ clinical trial nurse coordinator so everything is done and a potential participant just needs have an eligibility exam and to read through and give informed consent. All the services through the above search firms are free of charge.

From personal experience, I had molecular profiling done early on. That allowed me to focus my search. Still it took 14 months to find the perfect fit between between aspects of my case and the trial. I searched clinicaltrials.gov and PanCan.org weekly. As a former cancer researcher, I also was perusing the American Society of Clinical Oncology website one weekend as their annual meeting was underway. I saw an abstract just posted of a “proof of concept” trial detailing the results of the two participants. The abstract hinted a clinical trial was to result from the data.

I called clinicaltrials.gov and they knew and had nothing about it. Same for PanCan.org. So using the internet, I found contact info on the first author of the paper and called PanCan.org if they would call and make the introduction about my case. They did and that led to being the first enrolled in the trial and going on to have a complete response, achieving NED status 6.5 years ago and recently being declared cured using chemotherapy 10.5 years after having stage IV disease.

I have been trying to get into a new trial for xtx301 IL-12.Haven't gotten any answer to emails.

which trial did you do?

A clinical trial is to compare a new treatment or drug to an existing one if one currently exists. Or the trial can be a new class of drug for which no prior treatment exists. A trial is conducted in three phases with phase III more closely resembling real-world conditions. Conducting trials are costly and time consuming to collect the required amount of data for biostatistical analysis to determine if the new drug offers significant improvement and is as safe or safer.

There may be other companies testing a biosimilar compound. A case in point is the drug Olaparib (Lynparza) made by Astra Zeneca and the biosimilar compound Rucaparib (Rubraca) by Clovis Oncology. Astra Zeneca had a significant head start and is a much larger, cash-rich Pharma company. Their head start led to generating the required data and submitting it to the FDA which led to approved use for a number of cancers including pancreatic.

Clovis was a new entry and a small bio pharmaceutical company. They were testing their compound on Ovarian and breast cancers when it was learned there was potential for treating pancreatic cancer in what is a very small cohort.

With a well established Pharma company already having 100% of the available cohort to sell their Rx drug, a smaller company with the same drug is faced with trying to use critical funds to get approval for ovarian and breast which is a larger cohort for fighting to gain market share.

Now imagine if you are the head of a small bio Pharma with limited funding. Do you dilute critical resources and try to go after a tiny population of pancreatic cancer patients with mutations that may respond to a PARP inhibitor and jeopardize getting the drug through the breast cancer trials so application can be made to the FDA where approval could mean gaining a market share of a bigger patient cohort? It sometimes comes down to a make or break decision and whether a company survives. Bottom line-there is an FDAapproved PARP inhibitor available and helping pancreatic cancer patients with targetable mutations now. Another fact is it takes about 13 years from the discovery of a bio active compound to receive FDA approval.

To get a drug through FDA approval is also very expensive. Every time filings of documents are made to the FDA, it is not a one-time fee that covers the submission. It costs millions of dollars to cover those filings.

I have been trying to get into a new trial for xtx301 IL-12.Haven't gotten any answer to emails.

The trial was RucaPANC for maintenance monotherapy and targeted BRCA1, BRCA2, PALB2 mutations using the PARP-1 inhibitor Rucaparib (Rubraca).

More details on the trial-

PARP STUDY AT PennMedicine

This is a YouTube video of my case by pancreatic cancer oncologist Dr. Kim Reiss-Binder at PennMedicine. It starts at time stamp 1:00 and the conclusion is at the end of the presentation.

The trial was RucaPANC for maintenance monotherapy and targeted BRCA1, BRCA2, PALB2 mutations using the PARP-1 inhibitor Rucaparib (Rubraca).

More details on the trial-

PARP STUDY AT PennMedicine

This is a YouTube video of my case by pancreatic cancer oncologist Dr. Kim Reiss-Binder at PennMedicine. It starts at time stamp 1:00 and the conclusion is at the end of the presentation.