To hear about similar clinical trials, please enter your email below
Trial Title:
Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
NCT ID:
NCT06625320
Condition:
Pancreatic Cancer
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
Leucovorin
Paclitaxel
Gemcitabine
Oxaliplatin
Fluorouracil
Irinotecan
Conditions: Keywords:
Pancreatic Cancer
PDAC
Pancreatic Ductal Adenocarcinoma
RAS
KRAS
NRAS
HRAS
RAS Wild-Type
RAS Q61 Mutation
RAS G12 Mutation
RAS G13 Mutation
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RMC-6236
Description:
Oral Tablets
Arm group label:
RMC-6236
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
intravenous (IV) infusion
Arm group label:
Investigator's choice of standard of care therapy
Intervention type:
Drug
Intervention name:
nab-paclitaxel
Description:
IV infusion
Arm group label:
Investigator's choice of standard of care therapy
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
IV infusion
Arm group label:
Investigator's choice of standard of care therapy
Intervention type:
Drug
Intervention name:
Liposomal irinotecan
Description:
IV infusion
Arm group label:
Investigator's choice of standard of care therapy
Intervention type:
Drug
Intervention name:
5-fluorouracil
Description:
IV infusion
Arm group label:
Investigator's choice of standard of care therapy
Intervention type:
Drug
Intervention name:
leucovorin
Description:
IV infusion
Arm group label:
Investigator's choice of standard of care therapy
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
IV infusion
Arm group label:
Investigator's choice of standard of care therapy
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.
Detailed description:
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bindu Cherian
Phone:
310-633-8400
Phone ext:
16031
Email:
bcherian@mednet.ucla.edu
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10022
Country:
United States
Status:
Recruiting
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Susan Sharry
Phone:
801-585-3453
Email:
susan.sharry@hci.utah.edu
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Friedman
Phone:
703-636-1473
Email:
carrie.friedman@usoncology.com
Start date:
October 16, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Revolution Medicines, Inc.
Agency class:
Industry
Source:
Revolution Medicines, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06625320
