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

[Posts]

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.

[phil]

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 !!

[StephN]

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 (http://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

[jacqueline1102]

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

[phil]

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.

[StephN]

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.

[StephN]

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.

[Vicki revised]

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.

[StephN]

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 (http://clinicaltrials.gov/show/NCT01120561)

[phil]

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 !

[StephN]

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)

[StephN]

Site number 8 now open:

Dr. Paul (US Oncology, Colorado)

[StephN]

Another new site open:

Number 9 - Dr. Weisenfeld (Iowa Cancer Care)

[Redwolf8812]

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

[phil]

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 .

[Nancy L]

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.

[StephN]

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 (http://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

[Redwolf8812]

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

[schoonder]

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

http://www.clinicaltrials.gov/ct2/show/NCT01120561?term=emtansine&rank=15

[Redwolf8812]

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?

[phil]

Lorraine got into the original t dm-1 eap in 2010, w/ an extensive hx pf pre-treatment w/ all kinds of drugs, incl. a lot of adria , an anthracycline . in fact, she was txed w./ adria alone the last few weeks to get her into the eap, to keep her liver counts w/in eap limits. part of the argument to get her in was that since she was close to life-time limits on anthracyclines she would have to stop them soon anyway, then what ??
eap criteria in 2010 primarly focused on having progressed on her2 therapy, taxanes and tykerb. so i think some exposure to anthracyclines is very common in many t dm-1 candidates at this point

[StephN]

Three additional sites posted today.

Go to end of this thread under Clinical Trials:

http://her2support.org/vbulletin/showthread.php?p=284236#post284236

[yanyan]

FDA will make its decision on whether or not approving the drug by Feb 26,2013, does it mean if the drug does not get approved the trial will be closed? I hope they will approve it !!!

[StephN]

Can't imagine the FDA kicking back the T-DM1 application again!

THREE new T-PAS sites open for people to get the drug closer to home (making the total I have at 16 sites):

Two more sites just came in from Genentech:

15. Dr. Kenyon (Samaritan Oncology, OR)
Dr. Peter Kenyon
3640 Northwest Samaritan Drive Suite 161, Corvallis, OR 97330
Phone (541) 768-4950


16. Dr. Wolff (Johns Hopkins, MD)
Antonio C. Wolff, M.D., F.A.C.P.

410-955-8964
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, MD

[StephN]

Just got word of two more T-PAS sites for T-DM1 treatment opening.

17. Donald B Wender, PhD, MD
Siouxland Hematology Oncology
230 Nebraska St
Sioux City, IA 51101
(712) 252-0088
https://www.navigatingcancer.com/clinics/siouxland


18. Julie A. Means-Powell, M.D.
Vanderbilt-Ingram Cancer Center
691 Preston Building
Nashville, TN 37232
615-936-8422
http://www.vicc.org/

[StephN]

The work continues! Two more sites just opened - here it is the first week of January.

19. Denise Yardley, MD
Sara Cannon Research Institute
250 25th N Ave Suite 110
Nashville, TN 37203
877-MY-1-SCRI (877-691-7274)
http://sarahcannonresearch.com/


20. Ian Krop, MD
Dana Farber Cancer Institute
44 Binney Street
Boston, MA 02115
(617) 632-3000
http://www.dana-farber.org/

[StephN]

New T-PAS site just opening:

21.
Dr. Steven A Limentani
Carolinas Hematology-Oncology
Address: 1100 South Tryon Street, Charlotte, NC 28203

Phone (704) 446-9046

[StephN]

Redwolf -
Your doctor would have to check and see if you have had too much in the anthrocycline category. Hope not!

[StephN]

These sites for T-DM1 T-PAS continue to open at a good clip! Some of these were also early trial sites for this drug.


22. Jenny C. Chang, M.D.

The Methodist Hospital Research Institute
Director, Methodist Cancer Center
The Methodist Hospital
6565 Fannin Street
Houston, TX 77030
713-790-2700

Clinic Phone: 713-441-9948
Research Phone: 713-441-0629
Email: ccresearch@tmhs.org (ccresearch@tmhs.org)


23. Dr. Taral Patel
Mid Ohio Oncology
3100 Plaza Properties Blvd
Columbus, OH 43219
(614) 383-6000

[StephN]

Additional site to report:


24. Joanne Blum, M.D., ph.D., F.A.C.P.
Texas Oncology

Address: 3535 Worth St, Dallas, TX 75246
Phone (214) 370-1000

[StephN]

New T-PAS site just opened. T-DM1 has been given here, but now it has this designation.

25. Julie Gralow, MD
Seattle Cancer Care Alliance
825 Eastlake Ave E,
Seattle, WA 98109
(855) 557-0555
http://www.seattlecca.org/about-us.cfm (http://www.seattlecca.org/about-us.cfm)

[StephN]

Two more sites to announce. Maybe the last before the T-DM1 gets FDA approvel???

26. Dr. Kathy Albain
2160 S 1st Ave # 109
Maywood, IL 60153
Phone:(708) 216-9000





27. Dr. StanleyWaintraub
John Theurer Cancer Center
92 2nd Street
Hackensack, NJ 07601
Phone: 551-996-5864

[Steve A]

Does anyone know the status for T-DM1 FDA approval for Esophagus cancer treatment? There has been alot of good results in clinical trials.

['lizbeth]

http://www.cancer.gov/clinicaltrials/search/view?cdrid=737285&version=HealthProfessional&protocolsearchid=11850678

http://clinicaltrials.gov/show/NCT01641939

I see a phase III trial for advanced gastric her2 positive cancer. The first received date was July 2012, so I would guess it is too soon for approval.