Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

a study on Pancreatic Cancer Pancreatic Ductal Adenocarcinoma Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.

Official 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)

Details

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 Investigator's 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 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).

Keywords

Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, RAS, KRAS, NRAS, HRAS, RAS Wild-Type, RAS Q61 Mutation, RAS G12 Mutation, RAS G13 Mutation, Adenocarcinoma, Pancreatic Neoplasms, Leucovorin, Paclitaxel, Gemcitabine, Oxaliplatin, Fluorouracil, Irinotecan, RMC-6236, nab-paclitaxel, Liposomal irinotecan, 5-fluorouracil

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 PDAC with metastatic disease.
  • Measurable disease per RECIST 1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation)
  • Documented RAS mutation status, either mutant or wild-type. Eligible RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
  • Able to take oral medications.

You CAN'T join if...

  • Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  • History of or known central nervous system metastatic disease.
  • Any conditions that may affect the ability to take or absorb study treatment
  • Major surgery within 4 weeks prior to randomization.
  • Patient is unable or unwilling to comply with protocol-required study visits or procedures

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • Huntsman Cancer Institute accepting new patients
    Salt Lake City Utah 84112 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
ID
NCT06625320
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 460 study participants
Last Updated