RECRUITING

Study of RAS(ON) Inhibitors in Patients with Gastrointestinal Solid Tumors

Talk to us

Conditions

Colorectal CancerCRCPancreatic Ductal AdenocarcinomaPDACGastrointestinal CancerMetastatic Pancreatic Ductal AdenocarcinomaRAS MutationKRAS G12XPancreatic CancerPancreatic Ductal CarcinomaKRAS Q61 MutationKRAS G12 MutationRAS Wild-typeRAS G12D Mutation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The current subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel

Official Title

A Platform Study of RAS(ON) Inhibitors in Patients with Gastrointestinal Solid Tumors

Quick Facts

Study Start:2024-05-24
Study Completion:2027-07-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06445062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years of age
  2. * ECOG PS is 0 to 1
  3. * Adequate organ function as outlined by the study
  4. * Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, and C)
  5. * Presence of RAS G12D mutation (Subprotocol D, E, F)
  1. * Primary central nervous system (CNS) tumors
  2. * Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs
  3. * Major surgery within 28 days of first dose

Contacts and Locations

Study Contact

Revolution Medicines
CONTACT
1-844-2-REVMED
medinfo@revmed.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Revolution Medicines

Study Locations (Sites)

HonorHealth Research Institute
Scottsdale, Arizona, 85258
United States
UCLA Hematology/Oncology- Santa Monica
Los Angeles, California, 90404
United States
University of Colorado Hospital-Anschutz Cancer Pavilion
Aurora, Colorado, 88045
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center Main Campus
New York, New York, 10065
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Oncology Dallas
Irving, Texas, 75039
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22314
United States

Collaborators and Investigators

Sponsor: Revolution Medicines, Inc.

  • Study Director, STUDY_DIRECTOR, Revolution Medicines

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-24
Study Completion Date2027-07-15

Study Record Updates

Study Start Date2024-05-24
Study Completion Date2027-07-15

Terms related to this study

Keywords Provided by Researchers

  • CRC
  • PDAC
  • RAS Mutation
  • KRAS G12X
  • Colorectal Cancer
  • Pancreatic Cancer
  • Pancreatic Ductal Carcinoma
  • KRAS Q61 Mutation
  • KRAS G12 Mutation
  • RAS Wild-type
  • RAS G12D Mutation

Additional Relevant MeSH Terms

  • Colorectal Cancer
  • CRC
  • Pancreatic Ductal Adenocarcinoma
  • PDAC
  • Gastrointestinal Cancer
  • Metastatic Pancreatic Ductal Adenocarcinoma