Purpose of this Study
We are doing this study to find out if an experimental drug called RMC-6236 (the study drug) is a safe and effective option for people with metastatic pancreatic ductal adenocarcinoma (PDAC). We want to see how well the study drug works compared to the standard chemotherapy regimen for PDAC.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with PDAC, including adenosquamous carcinoma and poorly differentiated carcinoma
- Have confirmed metastases (evidence that the cancer has spread)
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to either:
- Get the study drug, which is a pill that you take once per day; OR
- Get whatever standard chemotherapy option the study doctor believes will be most beneficial for you
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Principal Investigator
Niharika
Mettu
Protocol Number
PRO00116619
NCT ID
NCT06625320
Phase
III
Enrollment Status
Pending Open to Enrollment