Purpose of this Study
In this study, you will be placed by chance into one of three groups. One group will get a medicine called daraxonrasib. Another group will get daraxonrasib plus two other medicines called gemcitabine and nab paclitaxel. The third group will get gemcitabine and nab paclitaxel without daraxonrasib. You will keep taking the study medicines as long as they are safe for you. The study is planned to last three years. Within thirty days after your last dose, you will have a follow up visit. After that, the study team will contact you every three months to check on your health until the study ends.
Who Can Participate?
Eligibility
People can join this study if they are 18 years or older and have a confirmed diagnosis of metastatic pancreatic adenocarcinoma, which means the cancer started in the pancreas and has spread to other parts of the body.
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
This study is being done to compare a new medicine called daraxonrasib to the usual chemotherapy used to treat metastatic pancreatic cancer. Researchers want to see if daraxonrasib by itself or daraxonrasib with the standard chemotherapy works better than the standard chemotherapy alone for people who are getting treatment for this cancer for the first time.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
[RMC-6236-303] RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma
Principal Investigator
Niharika
Mettu
Protocol Number
PRO00119867
NCT ID
NCT07491445
Phase
III
Enrollment Status
Open to Enrollment