Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733534
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2020-12-09
Brief Title:
An Open-Label Intervention Trial to Reduce Senescence and Improve Frailty in Adult Survivors of Childhood Cancer
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
SEN-SURVIVORS An Open-Label Intervention Trial to Reduce Senescence and Improve Frailty in Adult Survivors of Childhood Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first-in survivor pilot study with the goal of establishing preliminary evidence of efficacy safety and tolerability of two senolytic regimens to reduce markers of cellular senescence primary outcome p16INK4a and improve frailty primary outcome walking speed in adult survivors of childhood cancer If successful this pilot would provide the preliminary evidence needed for a phase 2 randomized placebo-controlled trial to establish efficacy
Primary Objective
The primary aim of this proposal is to test the efficacy of two short duration senolytic regimens 1 combination of Dasatinib plus Quercetin and 2 Fisetin alone to improve walking speed and decrease senescent cell abundance in blood p16INKA
Primary endpoints of this trial will be change in walking speed and senescent cell abundance in blood p16INK4A determined at baseline and again at 60 days within an individual arm Extended follow up at 150 days will assess the permanence of change after completion of the trial Secondary endpoints of this trial will be effect of intervention on additional measures of frailty beyond walking speed Fried criteria and on other cell senescence markers markers of inflammation insulin resistance bone resorption and cognitive function
Secondary Objectives
The secondary aim is to test the safety and tolerability of two different senolytic therapies
Exploratory Objectives
To compare the efficacy of the two senolytic regimens in improving walking speed and decreasing senescent cell abundance
To evaluate the longitudinal pattern in measures of frailty
Primary Objective
The primary aim of this proposal is to test the efficacy of two short duration senolytic regimens 1 combination of Dasatinib plus Quercetin and 2 Fisetin alone to improve walking speed and decrease senescent cell abundance in blood p16INKA
Primary endpoints of this trial will be change in walking speed and senescent cell abundance in blood p16INK4A determined at baseline and again at 60 days within an individual arm Extended follow up at 150 days will assess the permanence of change after completion of the trial Secondary endpoints of this trial will be effect of intervention on additional measures of frailty beyond walking speed Fried criteria and on other cell senescence markers markers of inflammation insulin resistance bone resorption and cognitive function
Secondary Objectives
The secondary aim is to test the safety and tolerability of two different senolytic therapies
Exploratory Objectives
To compare the efficacy of the two senolytic regimens in improving walking speed and decreasing senescent cell abundance
To evaluate the longitudinal pattern in measures of frailty
Detailed Description:
Eligible subjects who meet inclusion criteria will be randomized stratified on sex 11 and age 40 vs 40 to receive Dasatinib 100 mgday plus Quercetin 500 mg twice daily on days 1 2 3 30 31 and 32 taken orally or Fisetin 20 mgkgday alone on days 1 2 30 and 31 taken orally At the visit on day 7 we will assess blood CD3 T lymphocyte p16INK4A mRNA and other markers of inflammation and senescence to verify that senescent cells have been cleared by the intervention Post-treatment follow-up will occur on day 60 primary endpoints and day 150 to assess the permanence of change after completion of the trial Treatment adherence will be confirmed by the study coordinator who will administer the Dasatinib Quercetin in clinic on days 1 2 3 30 31 and 32 or Fisetin alone on days 1 2 30 and 31
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA246510 | NIH | None | httpsreporternihgovquickSearchU01CA246510 |