Why we wait on the TNBC trial to post to clinicalt
Post# of 154407
(Total Views: 370)
Posted On: 02/04/2019 9:03:53 PM
Why we wait on the TNBC trial to post to clinicaltrials and the PR on first patient injected.
He is another breast trial using CTC run by the same PI, Dr. Massimo Cristofanilli. Probably similar setup.
https://clinicaltrials.gov/ct2/show/NCT03213041
Hers is a link to more from him:
https://clinicaltrials.gov/ct2/results?cond=&...stofanilli
Including the CTC validation trial
https://clinicaltrials.gov/ct2/show/NCT00493350
Also researched some bookkeeping requirements below for those interested.
ClinicalTrials was updating and adding news trials during the shutdown.
https://clinicaltrials.gov/ct2/manage-recs/faq
Can I register a study after it has started, has closed to recruitment, or has been completed?
Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.
https://clinicaltrials.gov/ct2/manage-recs/fdaaa
Who Is Responsible for Registering Trials and Submitting Results?
The responsible party for an applicable clinical trial (ACT) must register the trial and submit results information. The responsible party is defined as:
The sponsor of the clinical trial, as defined in 21 CFR 50.3; or
The principal investigator (PI) of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for the submission of clinical trial information
Here is his quote from the PR again:
He is another breast trial using CTC run by the same PI, Dr. Massimo Cristofanilli. Probably similar setup.
https://clinicaltrials.gov/ct2/show/NCT03213041
Hers is a link to more from him:
https://clinicaltrials.gov/ct2/results?cond=&...stofanilli
Including the CTC validation trial
https://clinicaltrials.gov/ct2/show/NCT00493350
Also researched some bookkeeping requirements below for those interested.
ClinicalTrials was updating and adding news trials during the shutdown.
https://clinicaltrials.gov/ct2/manage-recs/faq
Can I register a study after it has started, has closed to recruitment, or has been completed?
Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.
https://clinicaltrials.gov/ct2/manage-recs/fdaaa
Who Is Responsible for Registering Trials and Submitting Results?
The responsible party for an applicable clinical trial (ACT) must register the trial and submit results information. The responsible party is defined as:
The sponsor of the clinical trial, as defined in 21 CFR 50.3; or
The principal investigator (PI) of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for the submission of clinical trial information
Here is his quote from the PR again:
Quote:
“In recent months, CCR5 as a cancer therapeutic target has become the focus of pharmaceutical clinical development with the activation of two prospective Phase 2 clinical trials using small molecular inhibitors of CCR5. In contrast with small molecule inhibitors of CCR5, we believe that the use of a monoclonal antibody such as PRO 140 can offer increased efficacy and a better safety profile,” stated Dr. Massimo Cristofanilli, a leader in the breast oncology field, medical oncologist and the Principal Investigator of the CytoDyn clinical trial notes. “As it stands now, TNBC is still an unmet medical need because it remains highly metastatic and difficult to treat. Novel therapies have to focus on targeting the metastatic process to improve outcome of these patients. In this study, we will measure clinical and biological endpoints, in addition to progression free survival, we will monitor Circulating Tumor Cells (CTC)’s in the blood,” added Dr. Massimo Cristofanilli. Noted Dr. Pestell, “The blood tests of CTCs will give us deep insight into what is happening on a real time basis and allow us to communicate our progress.
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