Why is it taking so long for Genentech to open the 176 sites?

7andcounting · 10-28-2011, 11:03 AM

Anyone have any idea how long it takes for a trial to actually open? www.clinicaltrials.gov says it is recruitng for the new TDM-1 trial, but if you go to locations---all 176 of them---only one has opened in NY and the other 175 say not recruiting.

Sept. 6th was the close date of the previous (open - enrollment) trial, so it is nearing 2 months since Genentech said they were opening this new trial.

I have called Genentech and they only say they have no new information as to the timing.

Refering to: NCT01419197

Thanks for any insight!

schoonder · 10-28-2011, 02:19 PM

7andcounting,

With the Emilia Her2+ MBC 2nd-line now fully enrolled (by the way, not updated in clinicaltrials.gov registry by sponsor) and Genentech getting ready to present FDA with their results by mid-2012 to get approval for 2nd-line MBC, which when received would include approval for levels beyond, could it be possible that urgency to get this trial fully underway isn't all there?

By directly contacting center(s) at which trial enrollment is contemplated with your question, it's possible to get a better feel for when trial may get started.

Hope this helps.

7andcounting · 10-28-2011, 03:11 PM

Hi Schoonder,

Thanks for your reply.

I wish I could contact the centers, however, only the city and state is given for the "location". That is my big question---it's coming to my state, but what center is going to get it? None of this has been revealed yet.

hutchibk · 10-28-2011, 04:49 PM

The IRBs (Independent Review Boards) of each clinic or family of clinics has to review the trial to see if it fits the clinic's mission (scope, logistics, etc) before it actually moves to the process of enrolling. If the IRB approves it, then it has to be coordinated with the sponsor of the trial with protocols and data collection requirements. There are quite a few details that must be decided and attended to before a clinic moves forward with a trial. It isn't only the sponsor, who takes what might seem like forever, to get a trial into place and moving to enrollment.

Hope this helps...

chrisy · 10-28-2011, 05:05 PM

Brenda's right - it can take what seems like forever...when I went on TDM1 I had to wait nearly a month after they had already done all that for "legal" to finish with the paperwork.

BTW I also found that even after I was enrolled and on study, the trials location list was not updated. So, not knowing what state you are in, I'd suggest you maybe contact the sponsor and if they can't tell you who is in "yet", they may be able to say who is considering it. Next bet would be to contact whatever major cancer centers there are in your area and ask directly.

It shouldn't be so hard...but sometimes it just is.

SoCalGal · 10-28-2011, 07:46 PM

My onc just told me that she is filling out the IRB paperwork and that Cedar's will have it, too. Cedar's is in Los Angeles.

hutchibk · 10-28-2011, 08:28 PM

It never hurts to just ask your Onc directly, too. They may know. Mine may end up getting it at his clinic if the IRB for the clinic's trials approves it...

ElaineM · 10-28-2011, 09:10 PM

In addition to the other reasons mentioned Genetech representatives have to make a site visit to each location that applies for a Genetech trial. The staff at each center must be trained for TDM1. That can take time.
The medical group here waited at least 6 months for a site visit for the Marrianne trial.They finally were ready for enrollment in July. Unfortunately only one patients qualified. They applied for the Theresa trial several months ago. The nurses told me they went to one training session for the Theresa trial so far. The NP told me she does not expect enrollment until March even though the doctors are hoping for December.

hutchibk · 10-29-2011, 09:23 AM

Hope all of this helps, 7... it just takes time from many different angles. It's not only Genentech's job to open the sites, and when the sites are approved, they must be trained... that also takes time.

StephN · 10-29-2011, 11:15 AM

If you are anywhere in the Great Northwest (read Washington, Oregon, Idaho) there is now a new trial at the Seattle Cancer Care Alliance which opened recently. I know of 2 or 3 patients at this time.

My onc is the principal investigator and I have had hints from her as to how long and hard she tried to get this here and off the ground.

ElaineM · 10-29-2011, 11:35 AM

Thanks for the information Steph. I am going to share it with the docs here in case anyone needs the Theresa trial right away and can't wait for it to start here. They were planning to send some patients to Fred Hutchinson last spring, but that center did not have approval at that time and they had to send some patients elsewhere.

StephN · 10-29-2011, 11:40 AM

Hi Elaine -
Fred Hutchinson is part of Seattle Cancer Care Alliance. The buildings are part of the same campus.

Treatment is NOT actually performed at "the Hutch" - that is the research arm. SCCA is the specialized building where cancer treatment is given.

Bone marrow transplants are still coordinated by the Hutch.

The Cancer Care Alliance is composed of the U. of Washington, Children's Hospital and the Hutch, thus easy to confuse.

ElaineM · 10-29-2011, 11:58 AM

Thanks Steph. I think the docs and NP were in contact with someone at Fred Hutchinson, but they knew about the Seattle Cancer Alliance, because they did talk about it in relation to what was going on during the spring.
I understand the Seattle Cancer Alliance. I think it is a good set up. I spent some time in Tacoma with friends over the years before I started participating here. I love Washington State. If I were to move to the mainland I would seriously consider Washington.

7andcounting · 10-29-2011, 08:45 PM

Hi All,

Thank you so much for all your replies. Well, a gal can always hope.....hoping these sites open soon. The good news is that my onc did make application to be one of the sites, but he has still not heard if he will get it. I'm just waiting and hoping.

I appreciate so much hearing people's thoughts on this. I guess I thought this kind of stuff happened faster!

Thanks!

7

Jackie07 · 10-29-2011, 09:08 PM

(I think) it was because of the blunder of Avastin (effective in other types of cancer, but not justified for Breast cancer), that the FDA became more cautious and insisted on the strict (standard) testing protocol for T-DM1.

Otherwise, T-DM1 would have been 'fast-tracked' and available everywhere by now. [You can use the 'Search' button to retrieve past threads on 'T-DM1' and 'T-DM!']

Lani · 10-29-2011, 10:59 PM

Jackie, I am not so sure avastin use is not justified in breast cancer. It may just be that they haven't identified the subgroup it works in (and the best combo to use it in). Dr. Slamon said that if they hadn't identified her2 and had a good test for it, herceptin would never have been approved, as it couldn't prove improved survival when tested on ALL breast cancer patients. Similarly, avastin may not improve survival when tested on ALL breast cancer patients, but may do so when tested on the correct subgroup.

I just hope they continue to let it be used so we can eventually find out if there is such a subgroup and who they are. It is amazing that they keep using anthracyclines on large subgroups on whom it does not improve survival (ER+ her2-s and even, at least according to Dr. Slamon, on all her2+s when TCH works as well and with fewer side effects). Perhaps it is because it is cheaper(as well as already approved)??

Sorry for getting on my soapbox...time to get off.