RASolute 302Daraxonrasib for Previously Treated Metastatic Pancreatic Cancer
RMC-6236
+ Gemcitabine
+ nab-paclitaxel
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: October 16, 2024
Actual date on which the first participant was enrolled.This clinical trial is designed to explore if a new treatment, called Daraxonrasib (RMC-6236), can help patients with metastatic pancreatic ductal adenocarcinoma (PDAC) live longer or slow down the progression of their cancer compared to existing standard chemotherapy treatments. It focuses on patients who have already received one type of chemotherapy, specifically those based on 5-fluorouracil (5-FU) or gemcitabine. The goal is to see if the new treatment provides better outcomes for these patients, which could potentially offer a better treatment option for this aggressive form of cancer. In the study, participants are randomly assigned to one of two groups. One group receives the new treatment, RMC-6236, while the other group receives a standard chemotherapy chosen by their doctor. The treatment is given in an open-label manner, meaning both the patients and doctors know which treatment is being administered. The study measures how long patients live without their cancer getting worse and their overall survival time. By comparing these outcomes between the two groups, researchers aim to determine the effectiveness and safety of RMC-6236 as a treatment option for those with advanced pancreatic cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.501 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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. 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 60 locations
Banner MD Anderson Cancer Center
Gilbert, United StatesOpen Banner MD Anderson Cancer Center in Google MapsMayo Clinic Cancer Center - Phoenix
Phoenix, United StatesCity of Hope-Duarte
Duarte, United StatesCedars-Sinai Medical Center
Los Angeles, United States