Expanded Mayo Trial
Posted: Tue Jul 10, 2018 12:21 am
Hi everyone - First time poster. My account was recently activated (thanks, BP!).
I've been anxious to share a few ideas and get some input and discussion. I was very interested to see that Janssen assumed management of the Mayo trial and expanded enrollment to 81 patients and re-positioned it as a Phase 2 trial. Using the archived history of changes on the clinicaltrials.gov site, you can see that the trial was updated in September of 2015 to increase enrollment from an actual of 56 to an anticipated of 80. Then the site was updated in November of 2015 to list an actual enrollment of 81. I believe 25 patients were enrolled between the 9/23/15 update and the 11/10/15 update. This OUTLINE was also added to the detailed description of the trial: "OUTLINE: Patients receive imetelstat sodium intravenously (IV) over 2 hours on day 1. Patients may continue to receive imetelstat study treatment for as long as they derive clinical benefit or until study end. The study will end when all patients have discontinued study drug, the last patient enrolled has been treated for 5 years, or imetelstat is commercially available in the United States, whichever occurs first."
https://clinicaltrials.gov/ct2/history/ ... 7&C=merged
I would not be surprised if Janssen uses this trial, with additional overall survival data from IMbark, as the basis for an application for accelerated approval. The 25 additional patients were enrolled prior to November 10, 2015. Janssen knows the overall survival status. Patients are living longer than expected. In the June 16, 2017 update to the trial, the primary completion date was pushed back from May 2017 to January of 2019.
I welcome your thoughts. Thanks to all for your contributions. I have enjoyed reading your quality information and analysis for some time.
I've been anxious to share a few ideas and get some input and discussion. I was very interested to see that Janssen assumed management of the Mayo trial and expanded enrollment to 81 patients and re-positioned it as a Phase 2 trial. Using the archived history of changes on the clinicaltrials.gov site, you can see that the trial was updated in September of 2015 to increase enrollment from an actual of 56 to an anticipated of 80. Then the site was updated in November of 2015 to list an actual enrollment of 81. I believe 25 patients were enrolled between the 9/23/15 update and the 11/10/15 update. This OUTLINE was also added to the detailed description of the trial: "OUTLINE: Patients receive imetelstat sodium intravenously (IV) over 2 hours on day 1. Patients may continue to receive imetelstat study treatment for as long as they derive clinical benefit or until study end. The study will end when all patients have discontinued study drug, the last patient enrolled has been treated for 5 years, or imetelstat is commercially available in the United States, whichever occurs first."
https://clinicaltrials.gov/ct2/history/ ... 7&C=merged
I would not be surprised if Janssen uses this trial, with additional overall survival data from IMbark, as the basis for an application for accelerated approval. The 25 additional patients were enrolled prior to November 10, 2015. Janssen knows the overall survival status. Patients are living longer than expected. In the June 16, 2017 update to the trial, the primary completion date was pushed back from May 2017 to January of 2019.
I welcome your thoughts. Thanks to all for your contributions. I have enjoyed reading your quality information and analysis for some time.