57 P3 Site Locations and Counting?

Forum rules
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Post Reply
kmall
Posts: 22
Joined: Thu Mar 21, 2019 3:57 pm

57 P3 Site Locations and Counting?

Post by kmall » Mon Aug 26, 2019 1:50 pm

Currently, there are 57 P3 locations listed on ClinicalTrials.gov -

https://clinicaltrials.gov/ct2/show/stu ... ocs=Y#locn

On June 5, I elicited a response from Jacob Goldberger regarding a request for consideration of a P3 site in Argentina:

Geron Investor Relations
Wed, Jun 5, 8:58 AM
to Investor, me

Dear Kmall,

We are confident in our new internal development team's ability to conduct the Phase 3 portion of IMerge. Our new development team is well-versed in running global clinical trials, including the Phase 2 portion of IMerge in lower risk MDS. The team has already selected sites to participate in the trial. As we disclosed in our Imetelstat Program Update on May 16, we expect the trial to be conducted at multiple medical centers globally, including North America, Europe, the Middle East and Asia.

We appreciate your enthusiasm for imetelstat. However, we have the right team in place already to execute on this very important objective for Geron.

-Jacob Goldberger, CG Capital


He clearly mentions the Middle East as a P3 location zone. As of now there are no locations listed in the Middle East. During my capaign of informing MDS patient groups globally there was a strong interest in Israel. Any possibility they could fill the Middle East spot?

If I'm not mistaken, originally P3 was to have enrolled 225 patients globally. It was scaled back to 170 - if I'm correct??

Any thoughts from those more knowledgeable in this arena if any more locations will be added? Or once they are listed on the ClinicalTrials.gove site is that a wrap?

Thanks for any input here and the BEST to all patients who have given of themselves in P3 so that approval may become a reality!! - Kmall

biopearl123
Posts: 223
Joined: Fri Jul 20, 2018 5:13 pm

Re: 57 P3 Site Locations and Counting?

Post by biopearl123 » Sat Aug 31, 2019 7:48 pm

Back in the USA! Sorry for the radio silence, have been on a long anticipated retirement trip of a couple of weeks. Also have been trying to deal with the now several thousand bogus registration attempts. Someone (s) want to make this site unusable. Can only assume its is some form of short attack since most of the discussion here is positive. Kmall, have missed your posts and am glad to see your recent thoughts. Yes, the study now is looking at 170 enrollees, a lower number than originally anticipated. I believe this reflects support for the idea that the statistical significance anticipated will be strong enough to be reflected in this smaller group with a 2:1 study drug to placebo ratio. I still think the KM curves will diverge early and the value of the drug could potentially be demonstrated early on in the MDS study. The actual study site seem to be altered a bit from what was originally anticipated and Kmall, I don't know if Jacob's information on the Middle East sites and South American sites he sent you in June are still valid. It has always interested me that Russia has several active sites (possibly thanks to their contribution to the world radioactivity quotient?) Anyway yes 57 sites are listed but I confess to being confused to the terminology of "completed". According to the clinical trials definition, a completed site is defined as "“Completed: The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred)”, so this might refer to sites that have completed their contribution to P2. On the other hand if the 57 is an accurate number then "completed" could refer to having identified some pre allotted number of patients to be enrolled in the study at any give site. (In other words to add validity to the study the patients need to be spread out over multiple sites and not weighted too much in one highly active site.) I can't be sure and will ask Jacob to clarify but honestly he has not been helpful to be in the past and does not seems well informed (hence your response from him regarding the Middle East and Argentina.) If "completed" is the former definition then the actual number of "active" sites would be far less than 57 so I do think we are owed some clarification here. Would welcome any thoughts to help clarify. If Scarlett is true to his word then patients should have started dosing now but to keep the study truly double blinded, they can't say anything until several patients have entered the study and the placebo patients can not be distinguished from the study patients at the time of an announcement. In the past, a PR seems to have accompanied dosing of the first patient(s). bp

Gwikley
Posts: 35
Joined: Thu Aug 30, 2018 9:05 pm

Re: 57 P3 Site Locations and Counting?

Post by Gwikley » Wed Sep 04, 2019 2:11 am

One of you folks help me understand the numbers... 57 locations, with 170 participants total?. That seems to equate to 3+ patients per location trial????

Secret Third Arm
Posts: 20
Joined: Tue Aug 28, 2018 3:26 pm

Re: 57 P3 Site Locations and Counting?

Post by Secret Third Arm » Wed Sep 04, 2019 1:45 pm

Look on the bright side, each patient will be able to be carefully monitored with such small numbers per center. I don't recall what (if any) dose modification is allowed, but the this bodes well for achieving the absolute best trial results possible.

biopearl123
Posts: 223
Joined: Fri Jul 20, 2018 5:13 pm

Re: 57 P3 Site Locations and Counting?

Post by biopearl123 » Wed Sep 04, 2019 5:54 pm

There is an understandable amount of confusion in my mind as to the actual number of sites that will be actively enrolling in Part II of the P III study. Those listed as "completed" on the surface look like they have completed enrollment in part II and are ready to treat. However, I don't know if this is true since "completed" by clinical trials definition refers to the last patient visit in a particular study. Thus "completed" could refer to those patients that have been enrolled in the part I study and have had their last patient evaluation as part of the study. Yes I am confused. So if 30 sites are listed as "completed" and if this refers to part I patients, that leaves 27 or so to enroll in part II. If however "completed" refers to completion of enrollment in part II for a given site then things are very far along (I doubt this based on past performance). Anyway I have written to Jacob to get clarification but don't hold out much hope since he has dodged me in the past. That some very experienced sites would not be enlisted to contribute patients seems unlikely. I do think there could be a maximum number of patients that would be allowable from any given institution so as to minimize any bias and shore up statistical validity. Multi center means multi center. I think the presenting authors from the various institutions around the world would want to be a part of part II and have the most experience in managing dose adjustments, adverse effects etc. So yes, it would be nice to have all of this clarified.

biopearl123
Posts: 223
Joined: Fri Jul 20, 2018 5:13 pm

Re: 57 P3 Site Locations and Counting?

Post by biopearl123 » Thu Sep 05, 2019 5:36 pm

I was pleased to get a prompt response from Jacob. The "completed" designation applies to part I of the study. I would hope these sites will be participating in part II but unless/until the clinical trials site is further updated we won't know. To summarize, "completed" does not mean those sites are locked and loaded with patients for part II. They might be but this is not reflected in the "completed" designation which refers to completion of part I. bp

kmall
Posts: 22
Joined: Thu Mar 21, 2019 3:57 pm

Re: 57 P3 Site Locations and Counting?

Post by kmall » Sat Sep 28, 2019 7:10 pm

Andrew-bp......Many thanks for the follow up with Jacob and subsequent breakdown of analysis on the inner workings of a drug phase enrollment. I'm still a bit foggy on the numbers and details - but it sounds as if many of those more knowledgeable in this arena are somewhat perplexed as well. When and if we get a final count and location listing I would to see where Imetelstat is being given. Great to have you back and hope your summer vacation was relaxing as I'm sure it was well deserved. All the best - Kmall

rccola335
Posts: 3
Joined: Sat Sep 28, 2019 10:00 pm

Re: 57 P3 Site Locations and Counting?

Post by rccola335 » Sun Sep 29, 2019 9:26 pm

the phase 2 always said phase 2/3 and nobody could ever explain why - there were 55 patients in the phase 2/3 - 170 +55=225 and I think this was the plan all along to continue those patients from 2/3 into phase 3

biopearl123
Posts: 223
Joined: Fri Jul 20, 2018 5:13 pm

Re: 57 P3 Site Locations and Counting?

Post by biopearl123 » Mon Sep 30, 2019 11:37 pm

rccola335, I think your math is correct and the total number of patients is as you say 225 but since the first 55 are not randomized, it is reasonable to suggest that part I will lack the statistical validity required by the FDA (no p value or Kaplan Meier curves). Part II should address this, but will take some time. In the meantime good news on the MF front. So why was the study set up this way? I think Janssen required it in order to limit costs and help make a decision to go all in or not. When they did the snapshot, they probably did not like what they saw, probably to our benefit. Part II will almost certainly be treated as a separate study. bp

Post Reply