← Return to Clinical Trials: they are not designed only to be a “last resort”

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@stageivsurvivor

I was the first patient in the US on the RucaPANC trial conducted from 2014-2016 testing the biosimilar PARPi to Olaparib called Rucaparib (Rubraca). I have a germline BRCA2 mutation and acinar cell carcinoma. I was the longest person in the trial and when the trial was terminated, had a complete response from this PARPi. The Principal Investigator who conducted the trial wrote an “Individual Patient-Investigational New Drug” protocol and applied to the FDA to allow me to continue on the drug under “Compassionate Need”. The request was approved in less than 24 hours resulting in no interruption in dosing. The company that was developing the drug sought approval for ovarian and prostate cancers for which it was approved. With a small market for pancreatic and Astra Zeneca having the pancreatic cancer market, the company did not look to spend limited resources on pancreatic when their next targeted market was breast cancer.

The company declared bankruptcy and the rights to Rubraca was bought by a company based in Europe. The former company and now the new company has been providing the PARPi since the trial ended in April 2016. I have taken it since and is very well tolerated. October 10 will make 10 years on the drug.

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Replies to "I was the first patient in the US on the RucaPANC trial conducted from 2014-2016 testing..."

Thanks very much for your time and information. Your results have brightened up my outlook csonsiderably and I'm hoping to have the same. I also have the BRCA2 germline mutation and from what I've been able to find out on how the PARP inhibitor drugs work, without that particular mutation, they are not effective. After reading how they work, it made sense to me even with my limited medical knowledge. And I assume the letter the Dr. at the NIH spoke to me about is along the same lines as the "compassionate need" letter that was written for your situation. Yeah, this is good news to me.