Revolu- daraxonrasib for first-line treatment of metastatic pancreatic adenocarcinoma(RMC-6236-303)

What is the 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.

What is the Condition Being Studied?

Metastatic pancreatic adenocarcinoma

Who Can Participate in the Study?

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 Group
Adults

What is Involved?

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.

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
Associate Professor of Medicine
Protocol Number
IRB: PRO00119867
NCT: NCT07491445
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF
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