Lapatinib trials?

michele u · 05-24-2006, 08:54 PM

Does anyone know the status of Lapatinib? The latest i knew is that they stopped the acurian trials because of success and they were going to fast track it. Does anyone know if there are any new trials that have started up? I'm still waiting to start this off label. I'm stage 3b.

Cathya · 05-25-2006, 06:33 AM

Michele;

I don't know the status but when I saw my onc yesterday he said that there was a clinical trial going on at our hospital in Ottawa, Canada....so there are still trials going on. This was for stage 3 or 4 progressing on herceptin. I realize that you want it as a prophylactic but at least it is available should you need it.

Cathy

MJo · 05-25-2006, 06:50 AM

The Helen Graham Cancer Center in Wilmington, Del. is also participating in a Lapatinib trial.

Shell · 05-25-2006, 12:52 PM

I have been on it for several months now, since they stopped the trial I was in - I see my onc next week, and will ask him what he knows...

Shell

RobinP · 05-25-2006, 01:28 PM

Lapatinib is not suppose to be released until late 2007, according to GSK.

Joe · 05-25-2006, 01:46 PM

GSK will apply to the FDA in the 2nd half of 2006 for approval of Tykerb (Lapatinib) It has already been fast tracked by the FDA so we are anticipating a swift approval.

We will be meeting with GSK in Atlanta next week and we will certainly discuss upcoming clinical trials as well as compassionate use of Tykerb prior to approval.

Warmest Regards
Joe

Sherryg683 · 05-25-2006, 08:04 PM

That's what I had read in Cure magazine, is that they will apply for approval the 2nd half of 2006. My Oncologist hopes he can get me approved to use it along with the Herceptin I am on. From reading the article in "Cure", it says that used along with Herceptin, it could be the 1--2 punch needed. I hope it isn't approved only for those who fail on Herceptin. Please keep us updated Joe..tks...sherryg683

lexigirl · 05-25-2006, 09:54 PM

Yes, please let us know. I'd like to try to give it my all before I have anymore mets.

RobinP · 05-26-2006, 06:20 AM

If you follow Dr. Spector's, a lead speaker for GSK, most recent research article on Lapatinib, you will note that it seems to turn on the estrogen receptor and that may need to be down regulated simultaneously with the erbs.See articles posted above for more details on this.I was also told that GSK does compassionate use but it takes about 8 months to get the medication once the paper work is filled.Hope this helps folks. And no as an early stager, I am not awaiting Lapatinib.

Sherryg683 · 05-26-2006, 06:50 PM

Joe, what exactly is meant by "compassionate" use?..sherryg683

athena453 · 05-26-2006, 10:22 PM

Michele, I understand where you're coming from. My onc said that there was a trial with concurrent herceptin and lapatinib for those with progression. I guess we have an unspoken agreement that I'll get lapatinib if I recur, but I hadn't thought of getting it prophylactically.

I'm with you, I'd rather not risk giving potential mets the opportunity to grow.