Anyone who is on BMN 673, a PARP Inhibitor clinical trial

I recall someone who was on the BMN637 PARP inhibitor clinical trial from UK and had good response, I would like to know how the trial goes.

Any information would be appreciated.

Thanks
Sunny123

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I am on the BMN-673 trial at the Simon Cancer Center in Indianapolis. Have just completed cycle 1. I have no measurable tumor, but my CA-125 decreased from 729 to 660. We were hoping for a bigger drop, but at least it is going in the right direction. First week side effects were slight headache, slight nausea, mildly feverish. But I really must say that none of those side effects trouble me any longer. I have good energy as well. I am 46, two kids at home. And a marvelous husband. I travel to Indy once a week to get the drugs and do labs. I live in Kansas City.

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Thanks donzi
I am about to have assessment in Jan for enter into the trial. Are you BRAC1/2 +? How often do they take blood sample and are you on part 2 dose escalation of the trail.

Sunny

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Dear Sunny:
BRCA 1. First diagnosed 3c in June 2009.

They take blood every week for the first three months. It is intense and a massive commitment of time/money. The screening was a long day of EKG, CT scan, bloodwork, consultations. They also had to have all of my med records from my oncologist.

The protocol calls for weekly blood-tests for three months, and on Day 1 of Cycles 1-3, they do a long timed set of blood tests (pre-dose, 30 min., 60 min., 2 hours, 3 hours, 4 hours, plus an EKG.) If I am still on the study after that, I will reduce my visits to twice monthly I believe. The study Doc said that this drug is the most potent PARP yet, and I am on the highest dosage (1000 mcg daily). Hoping this drug is the right path for me, but if not, I will go on Doxil. I am glad so many other Teal Gals are having great results with PARPs. Good Luck! and Cheers!

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I have been on BMN673 since March (nine months now) and it reduced my cancer by over 90%. My CA125 went from 204 down to 10. I was on 900mcg on the phase 1 dose escalation part of the trial. In November my scan showed that two of my tumours had grown slightly (and my CA125 had risen to 25) so I have now increased the dose to the full 1000mcg. My CA125 has not gone higher so hopefully the increased dose is doing something. I am due for scans next week so will find out.

I am BRCA1 - first diagnosed 2C in April 2009, recurrence in July 2010 and again in Dec 2011.

I have loved being on this new drug - I have had no nasty side effects - just slight queasiness for the first month but my bloods have been fine and my energy levels good. Being on a trial does involve many hospital visits for monitoring but for me it is so worth it. (I know however this trial has not been successful for all the patients that have tried it.)

Whatever happens following the scan I am so pleased to have had a year without having to have chemotherapy and where I have felt really well, been able to work all through, exercise, swim and go away on holidays!

Happy to answer any questions you may have.

Good luck and best wishes
Sharon

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Dear Sharonforce

Thanks so much for your information of the drug. I am going to have assessment appointment with Prof. Kaye in Jan and hopefully I can get into the trial. I am so glad that the drug works for you. I will let you know how I get on and get back on some of the questions.

Best wishes

Sunny

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Hi Everyone,

Is the trial still open?
What are the requirements?
I am stage 4 since 2008 with several recurrences.I recently had a PET/CT which was clear and my CA125 is 21

Thanks,
Sharon H.

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This is a link to open studies of BMN 673 http://www.clinicaltrials.gov/ct2/show/NCT01286987?term=biomarin&rank=22
Keep in mind that there are many more albeit statistically fewer genetic mutations for ovarian cancer out there. So if you think based on family cancers you have some sort of mutation but are BRCA negative get tested. The University of Washington is working on a study for about 12 other mutations. http://www.washington.edu/news/2011/10/25/linking-of-mutations-in-12-genes- to-ovarian-cancers-may-lead-to-more-effective-prevention/

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Hey Sunny,
Just checking in and seeing if you got on that BMN 673 trial?I have just completed Cycle 3 of the trial based in indianapolis. My CA 125 decreased altogether by around 500 points since I started; it's currently at around 200. I have no measurable tumor, so they are tracking me just on CA 125. Side effects included some dizziness, headache, nausea, but these were all brief and my body seemed to adjust rather quickly.
I will go to Indy every two weeks from now on, as long as I am getting benefit. Once resistance kicks in (which I have been told it definitely will), then I will go to Doxil.
Charon, I understand that you are off the trial and onto something new. I am glad that you had a very good year, and thank you for sharing your info....it was because of your posts that I pursued this trial. Hope your next treatment is also very tolerable and effective.
Cheers,
Donzi

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Hi Donzi
Yes you are right - I came off the trial on 1 January as it was no longer working for me. I don't regret doing the trial - I had a really good year. I have now just started on Carboplatin and Gemcitabine chemotherapy. I have also had a biopsy done on my tumours - the hospital are doing dna testing on the biopsy to see if/how it has changed due to the parp inhibitor drug.

Best wishes
Sharon

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