Now I'm Stage IV...and GSK Braf has been pulled???? Help! & Vent-Time.

Posted By
10/22/2010 5:19pm
View other posts by
Replies: 17

Dear Fellow Mellos;

Just talked with VERY helpful folks at Eastabrooke cancer center in Omaha.  They told me the GSK 2118436 B-raf drug trial phase II (NCT 011537630) had been pulled (terminated?) by FDA nationwide.  MDAnderson cannot seem to give me an answer at all.  I waited 5 long weeks for MDA to lemme know i was B-raf positive.  Now my CT scan 2 days ago show 3 Nodules OVER 1 cm. as well as the continued others.  I completed 1 yr. I-feron 3 mths. ago.

Does ANYONE know of a viable active B-raf trial available via GSK, Novartis, Roche, Bayer?, anyplace anywhere?  

I know i could get IPI, but i'm just not too impressed with the stats on it- maybe i'm wrong.  At least the B-raf drugs showed miraculous results- albeit short term;  AND  traditional IL-2 shows Proven long term results on around 10% of people.  I really wanted to do B-raf drug to at least buy some somewhat guaranteed time.

Any suggestions or trial knowledge greatly appreciated!

Love, Shady-Grady.

I'm Here for Now, I've got the rest of my life to die; and if so, old age could be overated and God does exist.

These are all  lung nodules BTW.  At least 10 with two 1.1 cm on each side of heart (paracardium) and one .9cm next to diaphram.  all still technically in lungs.

I'm Here for Now, I've got the rest of my life to die; and if so, old age could be overated and God does exist.

I just talked to someone this morning in Philadelpha, PA and they didn't say anything about the GSK Braf trial being pulled.  Don't know if it was the same number though.

I think that you have the wrong clinical trial number..I googled that number  it does not exit in the data base.

Everyone would be interested in knowing which trial has been pulled.

Please post further/or more info on the trial


good luck with your trial search

Sorry:  misstype:  REAL number is:    NCT 01153763

I'm Here for Now, I've got the rest of my life to die; and if so, old age could be overated and God does exist.

Thanks for info but I cannot find this trial in data base. Please provide the link to this clinical trial if you have it??? We all apppreicate this info. and you can help us out with the link or more info.

I don't know anything about whether this trial is being terminated or not, but this is the link:

I don't know about clinical trials, as David is still stage 3 and NED.  But wanted you to know that we were wondering how you were and wishing you the best and hoping you find a treatment to kick mels a$$!

I am on the Roche Braf trial.  Have you looked into this one?  




I am on vacation right now with my family so I will check back later it you found it.


Love and peace,

Shelly in Switzerland




I dont know what happened on that message.  I am typing on a keyboard in Italy and it is ALL confusing.  

At the bottom of that blob is the gov. trial number. 

Thanks Shelly-  Yes I have looked at this one.  However, it is randomised correct?  meaning of course you have a 1/3 or more chance of NOT getting B-raf drug.  I do not like this.  Correct me please if i am wrong- that would be great!

Love from the Swamps,  Grady.


PS- Hoffman/LaRoche has 1 trial in Zurich=  NCT 01164891 ;    US study # NP25158.

Would love to find excuse to go back to Switz.!

I'm Here for Now, I've got the rest of my life to die; and if so, old age could be overated and God does exist.

Grady where do  you live??? What location site was the BRAF clinical trial you were going to participatebefore it got terminated??????? Who told you the FDA terminated this braf trial???

Has anyone else been told of this FDA termination of this BRAF trial??

Hi There!  Check in with Sara Cannon, Nashville.  My brother is there taking GSK Braf- after nine months doing great!  They also have several other trials starting up.

Best of luck!


sister of Gary Stage (iv)

Thank You MrsMarilyn.  Actually, funny you mention Sarah Cannon- because when i talked with Estabroke in Omaha place to check on the B-raf GSK drug trial- which they did say was cnacelled or no longer available there at least (i know i'm not THAT crazy!)- they, the person in Omaha, recommended S. Cannon as a possibility for trials.

I'm so scared of saying something wrong or misleading at this pt.....but....i would like to ask about your brother, his trial, and perhaps the contact/Dr. that helped you at S. Cannon.  My email is:  if you feel comfortable sending me an "OK" so i could ask some things.   I'm finding out a lot of mixed-up contadictory info. re. the specific NON-randomised trial of GSK drug 2118436  and trial # NCT 01153763.  I assume this is the one your brother is on?

I'm Here for Now, I've got the rest of my life to die; and if so, old age could be overated and God does exist.

I've talked to the SC people before too and they are very nice.  If you can't find contact info email me and I'll get you some.  I think the 2113458 trials are on hold, or at least not recruiting.  I know when I was on it there were no openings.  I think they opened a combo with that drug w/ a MEK inhibitor.  I was not able to get cleared for it because of my brain mets.  No luck finding a PLX trial that would take me either.  So I am doing the ipi comp. use and hoping for the best.  I started this week in San Antonio.

Good luck and keep me posted on what you find!  I know it's frustrating to not be able to get your hands on it.  I literally felt my tumors decreasing in size after two days - and they almost completely disappeared and stayed gone 8 months.  Short term worth the longer term risk?  For me - you bet.  But hopefully the ipi will do its job and last long enough that the kinase inhibitor problems / complexities can be resolved.



I continue to praise God in this storm, counting my blessings & enjoying my "bonus time!"

Thanks so much Amy.  I was at MDA on 9-16th and even asked Dr. Wen-Jen Hwu about you - of course they couldn't tell me anything or even acknowledge your existence in this PC/HIPPA/Paranoid world.  Where did old fashion common sense go?? i'm there with probable Stage IV MM, slides, records, and my wife - and i might be a stalker ir something???  anyway, yeah i've been a bit bitchy lately (in a manly way of course).  Ya gotta laugh about things- its the only thing thats kept me alive even before MM!!!


I knew i'd count on you to understand my otta know, right?!  I hope the best for you re. IPI.  Lemme know how THAT goes as i have contemplated that.  I assume you may be on the trial where it is combined with Tremador?  I'll let ya know about what i "get" from the powers that be....including first and formost God, i reckon.

When you note the "stayed gone 8 months." - what treatment are you refering to?

Love & Take Care-  Grady.

I'm Here for Now, I've got the rest of my life to die; and if so, old age could be overated and God does exist.

I did a quick search on the open BRAF trials that are recruiting and found 16 that are recruiting and 1 that is not recruiting.

You may want to look at them to see if you meet any of their criteria.

I searchec by Melanoma and BRAF.  Good luck.



RankStatusStudy1Not yet recruitingA Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma.Conditions:Melanoma;   BRAF Mutant Metastatic Melanoma;   CancerInterventions:Drug: GSK2118436;   Drug: Dacarbazine (DTIC)2RecruitingStudy to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF InhibitorConditions:Melanoma;   CancerIntervention:Drug: GSK11202123RecruitingA Study of GSK2118436 in BRAF Mutant Metastatic MelanomaConditions:Melanoma;   BRAF Mutant Metastatic MelanomaIntervention:Drug: GSK21184364RecruitingInvestigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212Condition:CancerInterventions:Drug: GSK2118436;   Drug: GSK11202125RecruitingTemsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IVCondition:MelanomaInterventions:Drug: CCI-779;   Drug: AZD62446RecruitingA Study of RO5212054 (PLX3603) in Patients With BRAF V600-mutated Advanced Solid TumoursCondition:Colorectal Cancer, Malignant Melanoma, NeoplasmsIntervention:Drug: RO52120547RecruitingA Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid TumorsConditions:Melanoma;   Solid Tumor Cancer;   CancerInterventions:Drug: GSK2118436;   Drug: Midazolam8RecruitingMEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV MelanomaCondition:Melanoma (Skin)Interventions:Drug: MEK inhibitor AZD6244;   Genetic: gene expression analysis;   Genetic: mutation analysis;   Genetic: nucleic acid sequencing;   Other: immunohistochemistry staining method;   Other: laboratory biomarker analysis;   Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry9RecruitingA Study of RO5185426 in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic MelanomaCondition:Malignant MelanomaInterventions:Drug: RO5185426;   Drug: dacarbazine10RecruitingGenetic Risk Factors and Acquired Oncogenic Mutations of MelanomaCondition:MelanomaIntervention: 11RecruitingA Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic MelanomaCondition:Metastatic MelanomaIntervention:Drug: RAF26512RecruitingAZD6244 in Cancers With BRAF MutationsCondition:BRAF Mutation CancerIntervention:Drug: AZD624413RecruitingStudy of TAK-733 in Adult Patients With Advanced Nonhematologic MalignanciesConditions:Advanced Non-hematologic Malignancies;   Advanced Metastatic MelanomaIntervention:Drug: TAK-73314RecruitingAn Open-Label, 2-Cohort, Multicenter, Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV MelanomaCondition:Unresectable Stage III or Stage IV MelanomaIntervention:Drug: E708015RecruitingStudy of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant MelanomaCondition:Melanoma (Skin)Interventions:Genetic: gene expression analysis;   Genetic: polymerase chain reaction;   Genetic: polymorphism analysis;   Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry;   Other: medical chart review16RecruitingStudy of XL281 in Adults With Solid TumorsConditions:Cancer;   Non-Small-Cell Lung Cancer;   Colorectal Cancer;   Papillary Thyroid Cancer;   MelanomaInterventions:Drug: XL281;   Drug: famotidine17Not yet recruitingGenetic Identification (ID) of Segmental Dysplastic NeviCondition:Segmental Dysplastic NeviIntervention:Procedure: Punch Biopsy

Bill from Illinois
Stage IV Spine Mets, brain mets ans subq mets.
starting whole brain radiation on 11/8 and then compassionate use IPI ASAP.


If you are in the Midwest, you only need to go up the road.    Dr. Kahanic at Sioux City is doing the Braf trial, a phase 1 so you get the drug.    June Nylen clinic.   My wife was on it until she had new growth.