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nonsense, we hear over and over without a shred of evidence that the FDA mandated it, They didnt
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32 Studies found for: Glioblastoma | double blind placebo controlled
Also searched for Placebo-controlled, Placebo, Double-blinded and more. See Search Details
ah. I must be wrong, fda would never allow a non crossover trial, OOOOOPs
Brief Summary:
The main purpose of this study is to determine whether adding SurVaxM to standard-of-care temozolomide chemotherapy is better than temozolomide treatment alone for patients with newly diagnosed glioblastoma. This study is designed to compare the length of survival in patients with newly diagnosed glioblastoma who receive temozolomide plus SurVaxM to that of patients treated with standard-of-care temozolomide plus placebo. This study aims to discover what effects, both good and bad, this combination of drugs may have on you and to see if the study drug (SurVaxM) can create an immune response in your blood that is directed against your cancer cells. This study also aims to determine whether treatment with SurVaxM plus temozolomide improves the survival of glioblastoma patients like yourself compared to treatment with temozolomide alone.
Condition or disease Intervention/treatment Phase
Newly Diagnosed Glioblastoma Biological: SurVaxM Phase 2
CLINICAL TRIALS: IMMUNOTHERAPY| OCTOBER 01 2019
A Randomized Double-Blind Placebo-Controlled Phase II Trial of Dendritic Cell Vaccine ICT-107 in Newly Diagnosed Patients with Glioblastoma
Patrick Y. Wen;
David A. Reardon;
Terri S. Armstrong;
Surasak Phuphanich;
Robert D. Aiken;
Joseph C. Landolfi;
William T. Curry
;
Jay-Jiguang Zhu
;
Michael Glantz;
David M. Peereboom
;
James M. Markert;
Renato LaRocca;
Donald M. O'Rourke;
Karen Fink;
Lyndon Kim;
Michael Gruber;
Glenn J. Lesser;
Edward Pan
;
Santosh Kesari;
Alona Muzikansky;
Clemencia Pinilla;
Radleigh G. Santos;
John S. Yu
Author & Article Information
Clin Cancer Res (2019) 25 (19): 5799–5807.
Cancer
Original Article
Free Access
NRG/RTOG 1122: A phase 2, double-blinded, placebo-controlled study of bevacizumab with and without trebananib in patients with recurrent glioblastoma or gliosarcoma
Eudocia Q. Lee MD,Peixin Zhang PhD,Patrick Y. Wen MD,Elizabeth R. Gerstner MD,David A. Reardon MD,Kenneth D. Aldape MD,John F. deGroot MD,Edward Pan MD … See all authors
First published: 10 March 2020
https://doi.org/10.1002/cncr.32811
Citations: 12
We thank the NRG staff, particularly Minhee Won, Suzanne Baldwin, and Kathryn Okrent, for their help with the study.
ClinicalTrials.gov identifier: NCT01609790.
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Lol it is the official record according to the sponsor of what happened
Lol he is an oncologist not a regulator . Again there is zero proof the fda mandated the misguided crossover and in fact persuasive evidence they did not. But hey I am open minded let’s see the fda correspondence lol lol
oh and by the way why would the SAP Not mention the FDA mandate if there were one as thta is likely a key point to the regulators as the consider this mess of a trial
The SAP says nothing about the FDA.
do you have proof ???
right, so the fda confirmed that they did not mandate the crossover If fda approved the SAP, that is what it says
seem to me the exact opposite , the longs must be comong to the realization the dccrap is just that
only if one ignores the procedural mistakes
as a matter of fact I have
lots of clinical trial do not employ a crossover. particularly when SOC os part of the study. Lets ask LL:
On enrollment, patients were randomized 2:1 to either
DCVax-L or placebo, plus SOC. Randomization was performed centrally by independent co
apparently not LOL
and as of June 2022 no SOC according to Stupp. Thanks
ah, so Stupp NEVER said that this would be SOC, thanks
read the SAP
that's it??? that is the basis for saying it was clinically relevant. A controversial non fda mandated crossover
Yes did he say that dccrap was now that Soc? Lol lol
Lots of eye catching claims with zero proof
What criteria were used to conclude it was clinically relevant ?
thanks, still no proof
discussing a process is NOT the same as providing proof. No proof there
thanks. FACTS matter
criminal??? I must have missed it, was Ken G convicted???
but but but there was No highly successful p3 trial
interesting!!!!! got any proof???
hmmmmm sec filing TODAY
Linda F. Powers
Chairperson, President and Chief Executive Officer, Chief Financial and Accounting Officer
lol lol
94 sites, but relatively few patients and Jamaonc should be ashamed of the so called peer review
ah yes the publication with , shall we say , weak peer review. anyone with a computer or phone has heard the complaints about certain "decisions" re the data yet not a word
so no proof that a BLA has been filed, thanks I knew that LOL LOL
launch???? has she even submitted the BLA???? NO
yeah, she never launched a pharma product, but is teaching how to do that LOL LOL
hysterically funny
why no mention of the SAP that presents a very very different story????
LOL I dont have any questions for her. except why is does the SAP tell a different story ?????????????????hmmmmmmmm
thanks so if she is so precise, then it musr have been a deliberate omission, I was willing ro give her the benefit of the doubt, but that is just me
LOL hmmmm why did she not mention that fda did NOT mandate. Curious LOL
LOL oh it is the LP was at enron but didnt do any of the bad stuff LOL LOL