Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

Be sure to check the announcement posted at the top of each Forum from Genentech concerning the EMILIA study for T-DM1.

We will be posting updates to this announcement as they are made available to keep our members informed of the correct and most recent information concerning the study.

See all trials open to date by scrolling down through these posts.

Re: Check the announcement above from genentech on t-dm1
 

Its at the top of the Clinical Trials section on this board. They are offering Expanded Access to T DM-1 ! Any of you with high overexpression of her2, suffering w/ tyk / xel. or other lesser txs , Jump On It !!

Re: Check the ANNOUNCEMENT on t-dm1 - EAP sites UPDATES
 

From Genentech Advocacy Relations today, Aug 28, 2012:

The T-DM1 EAP is officially open with the first site in Lafayette, Indiana active.


Dr. Wael Harb
Horizon Oncology Center
1345 Unity Pl Suite 345
Lafayette, IN 47905
1-877-840-4926



Additional sites will be opening in the coming weeks. Please call Genentech's Trial Information Support Line for the most up to date information on eligibility and trial sites at 888-662-6728.

The clinicaltrials.gov posting for the T-DM1 EAP is now active and shows the eligibility criteria, as well as sites open. Please visit: http://clinicaltrials.gov/show/NCT01120561

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites updates
 

Hello all,

I live in Indianapolis, Indiana which is about 45 minutes south of Lafayette, Indiana (home to Purdue University). If you have any questions please let me know. I am sure the study will provide housing and such but I thought that if you needed any information about the area or just a chat, please let me know. Lafayette is in the middle of no where as far as the state goes but it is a nice little city. Low crime with the exception of the university students engaging in a little underage drinking. If you fly into the Indy airport you will notice that the whole process is rather easy and not very stressful at all, certainly in comparison to something like O'Hare.

Please let me know if any of you are going to participate in the study.

Take care,

Jackie

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites updates
 

I doubt any housing will beprovided. my wife had to make 16 trips to DC from Boston to get the drug under the original Exp. Access. We did get a small discount from Hampden Inn, fam and friends helped w/ the rest ( and some kind strangers as well ). I hope many other sites will open up soon. my wife is doing great , 22 months on it.

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites updates
 

TWO more sites just announced!

1. Elizabeth Tan-Chiu, M.D.
Florida Cancer Care
Plantation, FL 33324

2. Aminder Mehdi, MD
Stockton Hematology Oncology Medical Group, Inc.
Stockton, CA


Please call 888-662-6728 for more information.

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites updates
 

T-PAS site number 4 just opening:

New site for T-DM1 Expanded Access Program is now open in
Charleston, South Carolina at Charleston Hematology with Dr. David Ellison.

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites updates
 

Thanks for the update . I'm anxiously hoping for Atlanta, Birmingham, DC, or Gainesville (Mayo or Shands) since we have family/friends in those areas I could stay with.

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites updates
 

The 5th site for the T-DM1 Expanded Access Program is now open in Fairfax, Virginia with Dr. Robert.


For further info please visit: http://clinicaltrials.gov/show/NCT01120561

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

Awesome ! Fairfax ! Lorraines' " alma mater ". Thats where she was treated last yr. They ( and MGH ) saved her life. Dr. Robert is great, and his staff. They had exp access before , so they know what they're doing !

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

From Genentech Advocacy Relations today.

Two new EAP sites just announced:

6. Dr. Ibrahim (Beaver Med Group, Southern CA)

7. Dr. LoRusso (Karmanos Cancer Institute, Detroit, MI)

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

Site number 8 now open:

Dr. Paul (US Oncology, Colorado)

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

Another new site open:

Number 9 - Dr. Weisenfeld (Iowa Cancer Care)

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

How long do these EAP's usually stay open? Any ideas?

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

The last EAP program for T DM-1 was open about a yr and a half. Closed 9/11. This one should be open until This FDA approval, which is expected no later than 2/12 or 3 /12. My bet is they will issue appr. after the Election, on a Friday , maybe the Fri before Thanksgiving or Veterans Day. That is what they did when revoking Avastin, ( Fri before Thanks. ) and giving only conditional appr. for Pertuzumab ( June ). This FDA is even ashamed of past mistakes, but like many, can't admit it , or correct it .

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

Phil,

Sure hope your guess about an after Thanksgiving announcement is right. This 8 hr drive each way every three weeks will get old quick. I know others are traveling even further so they will feel the same way.

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

Here are EAP sites numbers 10 and 11, hot off the press from Genentech advocacy Relations:

10. Dr. Tracy Weisberg (Maine Cancer Ctr) (207) 885-7600
100 Campus Dr, Scarborough, ME 04074
www.mccm.org


11. Dr. Bethany Sleckman (St. John Mercy Medical, MO)
St. John's Mercy Medical Center
607 S New Ballas Rd Ste 3425
Saint Louis, MO 63141
(314) 251-6770

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

I hope someone can answer this question. Somebody told me that this Tdm1 eap is only open to Emilia trial patients. Is that true?

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

Penny, that's not true.
Clinicaltrials.gov link provide path to particulars to enroll in EAP trial.

http://www.clinicaltrials.gov/ct2/sh...ansine&rank=15

Re: Check the ANNOUNCEMENT on t-dm1 - Plus EAP sites UPDATES
 

I just noticed that one of the exclusion criteria is "History of exposure to cumulative doses of select anthracyclines". I received epirubicin with cytoxan as part of my neo-adjuvant treatment when I was still stage 3C. I wonder if this would prevent me from participating in the expanded access program?