Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641310
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Trial of Exercise Therapy in Familial Adenomatous Polyp FAP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1ab Trial of Exercise Therapy in Familial Adenomatous Polyp FAP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The study intervention being investigated in this phase 1ab trial is exercise therapy The form of exercise therapy will be aerobic exercise therapy comprised of supervised moderate-intensity treadmill walking
The primary objective of this study is to identify the most appropriate level the recommended phase 2 dose RP2D of exercise therapy for investigation in larger trials To identify the RP2D of exercise therapy we will conduct a phase 1a level-finding trial and a phase 1b level-expansion trial The phase 1a study is a level escalation trial evaluating 3 exercise levels 150 225 and 300 minutes per week with one de-escalation level of 90 minutes per week if required The phase 1b trial will further evaluate the highest feasible level and one LEVEL below identified in the phase 1a study
The primary objective of this study is to identify the most appropriate level the recommended phase 2 dose RP2D of exercise therapy for investigation in larger trials To identify the RP2D of exercise therapy we will conduct a phase 1a level-finding trial and a phase 1b level-expansion trial The phase 1a study is a level escalation trial evaluating 3 exercise levels 150 225 and 300 minutes per week with one de-escalation level of 90 minutes per week if required The phase 1b trial will further evaluate the highest feasible level and one LEVEL below identified in the phase 1a study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None