Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

a study on Pancreatic Cancer Pancreatic Ductal Adenocarcinoma Pancreatic Adenosquamous Carcinoma Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Official Title

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

Details

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.

Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib + gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).

Keywords

Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenocarcinoma, Pancreatic Adenosquamous Carcinoma, Pancreatic Ductal Adenocarcinoma, RAS, KRAS, NRAS, HRAS, RAS Wild-Type, RAS Mutation, Pancreatic Neoplasms, Gemcitabine, 130-nm albumin-bound paclitaxel, daraxonrasib, nab-paclitaxel, daraxonrasib + gemcitabine and nab-paclitaxel, gemcitabine and nab-paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  • At least 18 years old and has provided informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically or cytologically confirmed pancreatic adenocarcinoma.
  • Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
  • Documented RAS mutation status, either mutant or wild-type.
  • Measurable disease per RECIST v1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • Able to take oral medications.

You CAN'T join if...

  • Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.
  • Active or known history of untreated central nervous system metastatic disease.
  • Any conditions that may affect the ability to take or absorb study drug.
  • Major surgery within 28 days prior to randomization.
  • Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States
  • SCRI - Texas Oncology Dallas accepting new patients
    Dallas Texas 95246 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
ID
NCT07491445
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 900 study participants
Last Updated
Contact us about this trial