Let me first say that I shot those time estimates out without even writing anything down or thinking deeply about it...my apologies to all.
Well...after rethinking this in a sober state of mind with adequate coffee intake to achieve blood pressure that will register....
Using the " Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors "
https://clinicaltrials.gov/ct2/show/NCT04504942
Thoughts: If we want to put some timelines on this it's going to be difficult. Since there is no stated treatment duration, we have to extrapolate from the study dates milestones to what the treatment period was then figure what to with the post 12wk period. Also, if a patient dies during the study then their treatment period ends on that date - no 12w follow-up...so it's a confounder in trying to determine treatment period.. Without this data we're guessing in the dark...but here's my guess anyway....My guess is that drug treatment was 12m, add 12w to arrive at the Primary Outcome Measure of a 15m duration.
Picking this apart...
================
Actual Study Start Date : May 1, 2020
Definition: Study Start Date
My comments: This is most likely when the FIRST patient was accepted into the study by meeting entry criteria and signed their agreements. First dose probably followed not too long after that.
================
Actual Primary Completion Date: November 7, 2021
Definition: Primary Completion Date
My comments: I believe this is when the LAST enrolled patient met the primary outcome measures - which includes the 12w after study completion period per this "Primary Outcome Measure":
================
Estimated Study Completion Date: March 15, 2022
Definition: Study Completion Date
My comments: This is confusing as the secondary outcome measures indicate a 24m follow-up after completion of treatment. Maybe this is because of patients dying - IDK.
================
NOTE: On Sep 29, 2021, the study record was updated to reflect "Active, not recruiting" which means the last patient had already been enrolled prior to this date.
On Jan 13, 2022 the study record updated "Primary Completion: Nov 7, 2021 [Actual]".
================
The timeline in my mind....
May 1, 2020: First patient this date began, on or shortly after, treatment.
Aug 15, 2021: Last patient completed treatment medication if they survived until Nov 7, 2021. This is "Primary Completion Date" of Nov 7, 2021 minus 12w.
Note: At this point, 15m 14d has elapsed since first patient started study.
Late Sep 2021: Study updated as "Active, not recruiting".
NOTE: At this point, 16m 27d has elapsed since first patient started in study.
Nov 7, 2021: Last patient completed treatment + 12w - or dies.
(NOTE: This would indicate on the outside that "treatment + 12w" is no greater than 18m. And seeing how efficient Dr. Jr is, he had all these patients already lined up at the door.
NOTE: At this point, 18m 7d has elapsed since first patient started in study.
Jan 13, 2022: Study updated with "Primary Completion: November 7, 2021 [Actual]" and "Study Completion: March 15, 2022 [Anticipated]"
Mar 15, 2022: Estimated Study Completion Date (confusing based on my previous comments).
Really guessing from here down using 15m treatment (12m drug + 12w follow-up).
Aug 1, 2023: If first patient continued to survive, then the earliest date from the post 24 month follow-up.
Nov 7, 2023: If last patient continued to survive, then the earliest date from the post 24 month follow-up.
Well...after rethinking this in a sober state of mind with adequate coffee intake to achieve blood pressure that will register....
Using the " Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors "
https://clinicaltrials.gov/ct2/show/NCT04504942
Thoughts: If we want to put some timelines on this it's going to be difficult. Since there is no stated treatment duration, we have to extrapolate from the study dates milestones to what the treatment period was then figure what to with the post 12wk period. Also, if a patient dies during the study then their treatment period ends on that date - no 12w follow-up...so it's a confounder in trying to determine treatment period.. Without this data we're guessing in the dark...but here's my guess anyway....My guess is that drug treatment was 12m, add 12w to arrive at the Primary Outcome Measure of a 15m duration.
Quote:Study Design
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : November 7, 2021
Estimated Study Completion Date : March 15, 2022
Picking this apart...
================
Actual Study Start Date : May 1, 2020
Definition: Study Start Date
Quote:The actual date on which the first participant was enrolled in a clinical study.
My comments: This is most likely when the FIRST patient was accepted into the study by meeting entry criteria and signed their agreements. First dose probably followed not too long after that.
================
Actual Primary Completion Date: November 7, 2021
Definition: Primary Completion Date
Quote:The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures.
My comments: I believe this is when the LAST enrolled patient met the primary outcome measures - which includes the 12w after study completion period per this "Primary Outcome Measure":
Quote:Number, frequency, and severity of adverse events (AEs) [ Time Frame: From the time of first treatment until 12 weeks after study treatment completion ]
================
Estimated Study Completion Date: March 15, 2022
Definition: Study Completion Date
Quote:The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.
My comments: This is confusing as the secondary outcome measures indicate a 24m follow-up after completion of treatment. Maybe this is because of patients dying - IDK.
================
NOTE: On Sep 29, 2021, the study record was updated to reflect "Active, not recruiting" which means the last patient had already been enrolled prior to this date.
On Jan 13, 2022 the study record updated "Primary Completion: Nov 7, 2021 [Actual]".
================
The timeline in my mind....
May 1, 2020: First patient this date began, on or shortly after, treatment.
Aug 15, 2021: Last patient completed treatment medication if they survived until Nov 7, 2021. This is "Primary Completion Date" of Nov 7, 2021 minus 12w.
Note: At this point, 15m 14d has elapsed since first patient started study.
Late Sep 2021: Study updated as "Active, not recruiting".
NOTE: At this point, 16m 27d has elapsed since first patient started in study.
Nov 7, 2021: Last patient completed treatment + 12w - or dies.
(NOTE: This would indicate on the outside that "treatment + 12w" is no greater than 18m. And seeing how efficient Dr. Jr is, he had all these patients already lined up at the door.
NOTE: At this point, 18m 7d has elapsed since first patient started in study.
Jan 13, 2022: Study updated with "Primary Completion: November 7, 2021 [Actual]" and "Study Completion: March 15, 2022 [Anticipated]"
Mar 15, 2022: Estimated Study Completion Date (confusing based on my previous comments).
Really guessing from here down using 15m treatment (12m drug + 12w follow-up).
Aug 1, 2023: If first patient continued to survive, then the earliest date from the post 24 month follow-up.
Nov 7, 2023: If last patient continued to survive, then the earliest date from the post 24 month follow-up.
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