co1686 side effects management - 1270077

kkh130
Posts:39

Hello,

My dad started the study drug co1686 since April. Last scan shows tumer shrinkage, but his a1c level went up from 6.4 to 11.6 in two months. He just started metformin 500mg once daily 3 days ago. He complaints loss of appetite, fatigue, lack of energy, muscle spasms/cramps on hands and legs, orthostatic hypertension, and occasionally mild fever 99.3. He lost almost 10 lb in the past few months. The weight loss and loss of appetite are the major concern for him. He did not have these symptoms when he was on tarceva. I would like to know if his symptoms are mainly due to drug induced hyperglycemia. Any suggestions on how to deal with that?

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Reply # - June 8, 2015, 12:23 PM

catdander
Posts:

Unfortunately many of these symptoms could be from the treatment. Metformin is given for the drug induced hyperglycemia and hopefully will work for your dad. Since your dad is on a trial he has available to him the best care which should include close contact with the team about his symptoms. It's always important whether on trial or not to let the team know of symptoms. Fever and hypertension aren't adverse events shown on the co 1686 trial notes and would be important to let the team know of them and other symptoms. It maybe the side effects out weigh the benefits.

I hope he's feeling better soon,
Janine

Reply # - June 27, 2015, 08:33 AM

hain
Posts: 113

Hello kkh130, sounds good that your dad responded well to the trial med in terms of objective tumor response. Side effects are real in this trial for sure and the ones you described are not far from the ones my mom experienced in the past when she started the trial (Feb 2015). She is currently in cycle 6 and holding strong. Her side effects have been hyperglyecmia and loss of apetite and weight loss just as you described for your dad.

Hyperglyemia - metformin should do the trick. 500mg once a day might not be enough and he might need a dose increase or change in blood sugar medication to control sugar. Having said that, metformin tends to take several days-weeks in order to kick in and adaquately control blood sugar. You can try to have your dad take metformin concurrently with the clovis med- this has worked for my mom. My mom started with metformin 500mg once a day for 2 days, then 500mg twice a day, and now 1000mg twice a day.

Note: metoformin may induce nausea and loss of apetite in itself so a dose increase might worsen this symptom, something to discuss with your team. My mom experienced all of this but continued with metformin and added medical marijuanna and now has reached a stable managable side effect state.

Loss of appetite - has your dad tried medical marijuanna? Specifically, edible marijuanna has worked wonders for my mom, which has helped to drastically improve her apetite and in my opinion help control her hyperglyemia.

Stay strong and congrats on

Reply # - July 7, 2015, 02:06 PM

kkh130
Posts: 39

Hello hain, thanks for sharing your mom's treatment experiences. My dad couldn't tolerate metformin at a higher dose (has rash and stomach pain) and his blood glucose remained very high for more than a month (A1C 12.4). In order to bring down his sugar level, the doctor reduced his co1686 to 500mg twice daily from 625mg twice daily. Now his sugar under control. Before the dose reduction, he had another ct scan done to confirm the dramatic response showed on the previous scan. But this time inducates no change, no further tumor reductions. In the past week, I noticed he has more cough. I am kind of worry about him. I don't know how much it is going to affect the drug effect after reducing the dose. The doctor told me study showed the dose 500mg twice daily is better tolerated and most likely will be the dose submitted for FDA approval in future. I am trying to look for alternative treatment options for him in case it loses its effects.

Reply # - July 7, 2015, 03:57 PM

JimC
Posts: 2753

Hi kkh130,

It's good to hear that your dad's blood sugar is now under control. There are many causes for coughing, and in light of the scan showing stability, I wouldn't assume that the increase in coughing is cancer-related. Also, it is not uncommon at all to initially see tumor shrinkage followed by stability. Usually the great majority of shrinkage occurs at the outset of a new treatment, so although it's not a bad idea to be prepared for the next treatment choice, that decision may not be coming as soon as you fear.

And I hope that choice is a long way off!

JimC
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Reply # - July 8, 2015, 01:56 PM

const
Posts: 2

What does a dose reduction "mean" when using CO1686? Is a daily dose of 750mg less effective than a dose of 1000mg?

Thanks,
Const

Reply # - July 8, 2015, 02:19 PM

kkh130
Posts: 39

Hello const, my dad started co1686 at dosage of 625mg twice daily. Now the doctor decided to reduce his dose to 500mg twice daily because of the hyperglycemia side effect. I don't know the difference of effectiveness, but I think it should be fine. Just like tarceva, different dosage have been used depending on how the patient responds.

Reply # - July 9, 2015, 06:12 AM

catdander
Posts:

Dosage is determined during phase 1 of clinical trials and decided on by finding the highest possible amount that can be taken safely in following phases of the trials efficacy is determined though lower doses are never researched in the trials. So when prescribing the drug it dosed at the determined highest safe dose. If that isn't tolerable a lower dose may be better tolerated and still effective.

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