Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: daraxonrasib, gemcitabine, nab-paclitaxel.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma
Overview
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.
Detailed description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.
Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib + gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).
Interventions
- Drug daraxonrasib
oral tablets - Drug gemcitabine
intravenous (IV) infusion - Drug nab-paclitaxel
IV infusion
Primary outcome measures
- Progression free survival (PFS) [Time frame: Up to approximately 2 years]
- Overall survival (OS) [Time frame: Up to approximately 2 years]
Secondary outcome measures (8)
- Objective response rate (ORR) [Time frame: Up to approximately 2 years]
- Duration of response (DOR) [Time frame: Up to approximately 2 years]
- Concentration of daraxonrasib in Arm A and B [Time frame: Up to Cycle 5 Day 1 (each cycle is 28 days)]
- Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) [Time frame: Up to approximately 2 years]
- Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [Time frame: Up to approximately 2 years]
- Incidence of adverse events (AEs) [Time frame: Up to approximately 2 years]
- Changes in vital signs [Time frame: Up to approximately 2 years]
- Changes in clinical laboratory test values [Time frame: Up to approximately 2 years]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- Honor Health Research Institute — Scottsdale
- H Lee Moffitt Cancer Center and Research Institute — Tampa
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore
- Dana-Farber Cancer Institute — Boston
- Comprehensive Cancer Centers of Nevada — Henderson
- Memorial Sloan Kettering Cancer Center — New York
- University of Cincinnati Cancer Center — Cincinnati
- Taylor Cancer Research Center — Maumee
- … and 5 more centers
Japan · 6 centers
- National Cancer Center - East — Kashiwa
- Cancer Institute Hospital - Japan Foundation for Cancer Research — Koto-Ku
- NHO Kyushu Cancer Center — Fukuoka
- Kanagawa Cancer Canter — Kanagawa
- Wakayama Medical University Hospital — Wakayama
- Yamaguchi University Hospital — Yamaguchi
Australia · 1 center
- Calvary Mater Newcastle — Waratah
Identifiers
NCT: NCT07491445 · RMC-6236-303