LY2801653 clinical trial
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Ha, Kris….I might see you soon. Think a trip to Philadelphia is in my plans.
Want to see that smile of yours.
Hugs,
MarionAnd I thank God for that!! I don’t know if you would recognize me anymore… Now when I smile it actually reaches my eyes!
I even get to lose 1 visit day now! Every 4 weeks I’ve been going in Day 28 (or close) and day 1. Now I get to skip day 28 on my non-ct scan cycles! That means I’m down to 3x in 8 weeks!! Joy!
If I had known, my flight home would have been a different day! Oh, well…Kris…the additional treatment arms must have been released just recently. Phase I trials are designed to determine the toxicity level tolerable to humans. Based on data not yet released and/or accumulated, phase II and Phase III trials are designed.
Part D of this trial is to establish how much LY2801653 can be tolerated when combined with another drug, Cisplatin. At this point, no one has the answer. Hence we call it: clinical “research” studies.
Ideally, these types of studies are conducted on people never exposed to toxins of any kind. But, obviously, this is not possible. The next, best alternative is to recruit people with no prior treatment. That often is not possible, because life threatening diseases such as ours, are aggressively attacked with drugs or radiation, which in turn cause molecular changes within the cancer cells.
The investigators of this study work closely with the pharmaceutical company providing the drug. Based on their combined data, LY2801653 and Cisplatin can be administered to those with one prior chemotherapy regimen (not more) and still reveal acceptable new data for this drug combination in re: to acceptable toxicity levels of LY2801653.But for you, things are different. You may continue on to cisplatin and LY2801653 or eliminating LY2801653 due to toxicity levels or the cisplatin for other reasons or, you may very well stay on LY2801653 indefinitely.
You are doing so incredibly well and that is simply fantastic.
Hugs
MarionHmmm. I haven’t had toxicity problems, as far as I know. So that’s good! And I just started cycle 10. I’m perfectly happy with it so far.
I thank you for the further info which I was unaware of. I’m hoping some members may be able to benefit from this trial, too.Kris… Part D consists of dose determination for LY2801653 in combination with cisplatin in participants with cholangiocarcinoma followed by an expansion cohort. •Part D – Diagnosed with cholangiocarcinoma and have not received more than 1 prior systemic therapy.
There still is the option of below.
25mg/m2 Cisplatin given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, Cisplatin may be continued as monotherapy until progression of disease. Participants discontinuing Cisplatin therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit.
It clearly states that LY2801653 will be halted if and when toxicity to drug presents after a minimum of 4 cycles. Only then monotherapy with Cisplatin can be administered until disease progresses. In that case, LY2801653 can be used again.
Seems that options are available.
Hugs,
MarionLainy, I just reread this: it is misleading! I am still in phase 1. I would not be eligible for phase 2! I don’t know if I could change to phase 2 if it proves even better. But since all is great here, I don’t know that I would want to!
I heard today that the Phase II has started. It is being paired with Cisplatin. BUT the entrance rules have changed. Now you must have only had one path of treatment. So even I am not eligible for Phase II!
They are expanding this trial… Phase 2: New study pairing it with cisplatin. I don’t know if it will be offered elsewhere… I am unable to participate in this for at least 6-12 months. We shall see how the pairing works first. My oncologist doesn’t understand the drug choice since cisplatin is never administered alone.
I met someone today with colon cancer that tried this trial at Phase 1, and it did not work. He gas moved to another trial, which is giving him bad reactions. I feel so bad for him, and wish I could do something…So true, Kris, everyone should have the opportunity to enter a clinical trial. First and foremost, Clinical trials are “research studies” which determine a drug efficacy via Phase I through Phase III and the ongoing Phase IV studies. This is it in a nutshell.
Secondly, patients may or may not benefit from the clinical trial. This is especially true for Phase I studies for the reason mentioned above. I agree with you in that everyone should be given a chance to better his/her situation. But there has to be some regulation put in place in order to protect those desperately trying to find answers to their illness.To recap: Clinical research studies are designed to help future patients, but also may be beneficial to the current patient population. The absolute fantastic news is that the currently mentioned Phase I trials on our site have shown to be extremely beneficial to numerous people including you. And, how much better can it get?
Hugs,
MarionThanks, Marion. It’s just too bad that people who are “sick” and running out if options can’t be in most of these trials. I mean, what do they have to lose? I understand the reasoning, but I just wish there were an “invisible” test group.
Us patient advocates working in the NCI clinical trial setting are very much aware of the rulings set forth in re: to clinical trial adherence. Phase I clinical trials determine the toxicological effect on generally healthy people. It would be difficult to determine whether the adverse effects are related to the ill health of the person or whether it would represent a side effect of the medication. Additionally and most importantly though, humans must be protected in research studies. Phase I clinical trials are designed to measure the toxicity or side effect of a drug because, at this point, no one knows what is too much and how much can a person handle. Due to the abuse of humans in research studies the HUMAN SUBJECT PROTECTIONS guidelines were put in place. The pharmaceutical industry has to abide by the rulings as does everyone else conducting clinical trials. The FDA will not approve a clinical trial unless strict adherence to the guidelines is practiced.
Hugs,
Marion
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