Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625320
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma PDAC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RASolute 302 a Phase 3 Multicenter Open-label Randomized Study of RMC-6236 Versus Investigators Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma PDAC
Status:
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:
RASolute 302
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of a novel RASON inhibitor compared to standards of care SOC treatment
Detailed Description:
This is a global randomized open-label Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival PFS or overall survival OS compared to Investigators choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil 5-FU based or gemcitabine-based regimen
Patients will be randomized in a 11 ratio to receive RMC-6236 Arm A or Investigators choice of standard of care chemotherapy Arm B
Patients will be randomized in a 11 ratio to receive RMC-6236 Arm A or Investigators choice of standard of care chemotherapy Arm B
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