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Clinical Trials in Italy / NCT07491445
Recruiting Phase 3

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

NCT07491445 · tracked via the Priya Life Science Italy tracker
Sponsor
Revolution Medicines, Inc
Phase
Phase 3
Started
2026-03-09
Last updated
2026-10-02

Condition(s) studied

Pancreatic CancerPancreatic Cancer MetastaticPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma MetastaticPancreatic AdenocarcinomaPancreatic Adenosquamous Carcinoma

Investigational drug(s) / intervention(s)

daraxonrasib →gemcitabine →nab-paclitaxel →

daraxonrasib: oral tablets

gemcitabine: intravenous (IV) infusion

nab-paclitaxel: IV infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Progression free survival (PFS) — Up to approximately 2 years
    PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.
  • Overall survival (OS) — Up to approximately 2 years
    OS is defined as the time from randomization until death from any cause.

Trial sites (82)

FacilityCityRegionStatus
Mayo Clinic - Scottsdale Phoenix Arizona Active Not Recruiting
Honor Health Research Institute Scottsdale Arizona Active Not Recruiting
University of California Los Angeles Health - Hematology/Oncology Los Angeles California Active Not Recruiting
University of California San Francisco San Francisco California Active Not Recruiting
Mayo Clinic Cancer Center- Florida Jacksonville Florida Active Not Recruiting
H Lee Moffitt Cancer Center and Research Institute Tampa Florida Active Not Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland Active Not Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Active Not Recruiting
Henry Ford Health System Detroit Michigan Active Not Recruiting
Mayo Clinic Cancer Center- Rochester Rochester Minnesota Active Not Recruiting
Comprehensive Cancer Centers of Nevada Henderson Nevada Active Not Recruiting
Memorial Sloan Kettering Cancer Center New York New York Active Not Recruiting
Duke University Medical Center Durham North Carolina Active Not Recruiting
University of Cincinnati Cancer Center Cincinnati Ohio Active Not Recruiting
Taylor Cancer Research Center Maumee Ohio Active Not Recruiting
SCRI Oncology Partners Nashville Tennessee Active Not Recruiting
SCRI - Texas Oncology Dallas Dallas Texas Active Not Recruiting
MD Anderson Cancer Center Houston Texas Active Not Recruiting
Huntsman Cancer Institute Salt Lake City Utah Active Not Recruiting
Virginia Cancer Specialists Fairfax Virginia Active Not Recruiting
Virginia Mason Medical Center Seattle Washington Active Not Recruiting
St. George Hospital Kogarah New South Wales Recruiting
Prince of Wales Hospital Randwick New South Wales Recruiting
Calvary Mater Newcastle Waratah New South Wales Recruiting
Royal Brisbane and Women's Hospital Herston Queensland Recruiting
Epworth HealthCare East Melbourne Victoria Recruiting
Austin Health, Olivia Newton-John Cancer Research & Wellness Centre Heidelberg Victoria Recruiting
Krankenhaus der Barmherzigen Brüder Wien-Klinisch wissenschaftliche Studien Vienna Austria Recruiting
Institut Jules Bordet Anderlecht Belgium Recruiting
UZ Leuven (Univ Ziekenhuis Leuven) Leuven Belgium Recruiting
CEPON - Centro de Pesquisa Oncologicas de Santa Catarina Florianópolis Santa Catarina Recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia São Paulo Brazil Recruiting
Sunnybrook Research Institute Toronto Ontario Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
McGill University - Dept. Oncology Clinical Research Program Montreal Quebec Recruiting
Klinikum der Universitaet Muenchen Campus Grosshadern München Germany Recruiting
The Chinese University of Hong Kong Hong Kong Sha Tin Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy Recruiting
Istituto Oncologico Veneto IRCCS Padova Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy Recruiting

+ 42 more sites — see the full list on the official registry below.

More Revolution Medicines, Inc. trials in Italy

Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC Recruiting
Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) Recruiting
Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Active, not recruiting
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) Recruiting
Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors Recruiting

Other trials for the same condition

Prospective Registry of Young-Adult Patients Diagnosed With Pancreatic Cancer Recruiting
Advanced Therapies for Liver Metastases Recruiting
PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum) Starting soon
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) Active, not recruiting
Prehabilitation in Pancreatic Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07491445 on ClinicalTrials.gov ↗ ← All trials in Italy