Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Recruiting · NCT07491445 · Interventional (participants receive a specific treatment) · Lead sponsor: Revolution Medicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
33 locations listed across 13 US states.
- Honor Health Research Institute - Scottsdale, Arizona, United States
- University of California San Francisco - San Francisco, California, United States
- H Lee Moffitt Cancer Center and Research Institute - Tampa, Florida, United States
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Comprehensive Cancer Centers of Nevada - Henderson, Nevada, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- University of Cincinnati Cancer Center - Cincinnati, Ohio, United States
- Taylor Cancer Research Center - Maumee, Ohio, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- SCRI - Texas Oncology Dallas - Dallas, Texas, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- Huntsman Cancer Institute - Salt Lake City, Utah, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- Virginia Mason Medical Center - Seattle, Washington, United States
- Queen Elizabeth Hospital - Birmingham - Birmingham, United Kingdom
- Chiba Cancer Center - Chiba, Japan
- NHO Kyushu Cancer Center - Fukuoka, Japan
- Kyushu University Hospital - Fukuoka, Japan
- Kanagawa Cancer Canter - Kanagawa, Japan
- Barts Hospital - London, United Kingdom
- Royal Marsden Hospital - London - London, United Kingdom
- Osaka International Cancer Institute - Osaka, Japan
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - São Paulo, Brazil
- National Taiwan University Hospital - Taipei, Taiwan
- National Cancer Center - Tokyo - Tokyo, Japan
- Wakayama Medical University Hospital - Wakayama, Japan
- Yamaguchi University Hospital - Yamaguchi, Japan
- National Cancer Center - East - Kashiwa, Chiba, Japan
- Prince of Wales Hospital - Randwick, New South Wales, Australia
- Calvary Mater Newcastle - Waratah, New South Wales, Australia
- Cancer Institute Hospital - Japan Foundation for Cancer Research - Koto-Ku, Tokyo, Japan
- Epworth HealthCare - East Melbourne, Victoria, Australia