Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592664
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
LSTA1 Phase 1b2a Continuous Infusion Trial in mPDAC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b2a Double-blind Placebo-controlled Three Arm Randomized Study Evaluating Continuous Infusion of LSTA1 Over 4 Hours When Added to Standard of Care SoC Versus a Single Intravenous IV Push of LSTA1 When Added to SoC Versus SoC Alone in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma mPDAC Who Have Progressed on FOLFIRINOX FORTIFIDE
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:
FORTIFIDE
Brief Summary:
The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma
The main questions it aims to answer are
is the new drug plus standard treatment safe and tolerable
is the new drug plus standard treatment more effective than standard treatment
Participants will
Visit the clinic three times every 28 days for treatment and tests
Have CT or MRI scans every 8 weeks while on treatment
The main questions it aims to answer are
is the new drug plus standard treatment safe and tolerable
is the new drug plus standard treatment more effective than standard treatment
Participants will
Visit the clinic three times every 28 days for treatment and tests
Have CT or MRI scans every 8 weeks while on treatment
Detailed Description:
This is a Phase 1b2a double-blind placebo-controlled three-arm randomized study evaluating continuous infusion of LSTA1 over 4 hours when added to standard of care SoC versus a single intravenous push of LSTA1 when added to SoC versus SoC alone in people with metastatic pancreatic ductal adenocarcinoma mPDAC who have progressed on FOLFIRINOX
The study will consist of a screening period a run-in period a treatment period an end-of-treatment follow-up visit and a long-term follow up period
Participants who provide informed consent will be screened for eligibility within 28 days prior to beginning the study treatment run-in period Once eligibility is confirmed participants will be randomized to one of the three treatment groups
During the 3-day run-in period participants will only receive the LSTA1 or placebo components of their randomized treatment regimen After the 3-day run-in Cycle 1 of treatment will commence Tumor scans will be performed every 8 weeks 56 days 7 days while on treatment
The study will consist of a screening period a run-in period a treatment period an end-of-treatment follow-up visit and a long-term follow up period
Participants who provide informed consent will be screened for eligibility within 28 days prior to beginning the study treatment run-in period Once eligibility is confirmed participants will be randomized to one of the three treatment groups
During the 3-day run-in period participants will only receive the LSTA1 or placebo components of their randomized treatment regimen After the 3-day run-in Cycle 1 of treatment will commence Tumor scans will be performed every 8 weeks 56 days 7 days while on treatment
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