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

NCT07491445
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
900
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Lead sponsor
Revolution Medicines, Inc.
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Start date
2026-03-09
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Number of sites
82
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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.
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Acronym
RASolute 303
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Short title
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-03-01
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First posted
2026-03-24
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Registry last updated
2026-10-02
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Primary completion date
2028-06-01
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Start date
2026-03-09
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Participants
900
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Participant count basis
Estimated
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Planned participants
900
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Protocol amendments
1
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Number of sites
82
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Revolution Medicines, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07491445
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ClinicalTrials.gov ID
NCT07491445
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Progression free survival (PFS)

    Timeframe: 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.

  2. Overall survival (OS)

    Timeframe: Up to approximately 2 years

    OS is defined as the time from randomization until death from any cause.

  1. Objective response rate (ORR)

    Timeframe: Up to approximately 2 years

    Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator.

  2. Duration of response (DOR)

    Timeframe: Up to approximately 2 years

    DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the investigator.

  3. Concentration of daraxonrasib in Arm A and B

    Timeframe: Up to Cycle 5 Day 1 (each cycle is 28 days)

    Pre-dose trough and post-dose blood concentrations of daraxonrasib at selected visits.

  4. Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26)

    Timeframe: Up to approximately 2 years

    EORTC QLQ-PAN26 consists of 26 items assessing patient-reported health-related quality of life, including symptoms and impacts. Change from baseline in the pain subscale scores will be evaluated, with higher scores indicating greater symptom burden.

  5. Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Timeframe: Up to approximately 2 years

    EORTC QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. Change from baseline in EORTC QLQ-C30 global health status will be assessed, with higher scores reflecting better functioning.

  6. Incidence of adverse events (AEs)

    Timeframe: Up to approximately 2 years

    Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5

  7. Changes in vital signs

    Timeframe: Up to approximately 2 years

    Number of patients with clinically significant changes in vital signs

  8. Changes in clinical laboratory test values

    Timeframe: Up to approximately 2 years

    Number of patients with changes from baseline in clinical laboratory test values

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Mayo Clinic - ScottsdalePhoenix, United StatesActive, not recruiting
  • Honor Health Research InstituteScottsdale, United StatesActive, not recruiting
  • University of California Los Angeles Health - Hematology/OncologyLos Angeles, United StatesActive, not recruiting
  • University of California San FranciscoSan Francisco, United StatesActive, not recruiting
  • Mayo Clinic Cancer Center- FloridaJacksonville, United StatesActive, not recruiting
  • H Lee Moffitt Cancer Center and Research InstituteTampa, United StatesActive, not recruiting
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, United StatesActive, not recruiting
  • Dana-Farber Cancer InstituteBoston, United StatesActive, not recruiting
  • Henry Ford Health SystemDetroit, United StatesActive, not recruiting
  • Mayo Clinic Cancer Center- RochesterRochester, United StatesActive, not recruiting
  • Comprehensive Cancer Centers of NevadaHenderson, United StatesActive, not recruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesActive, not recruiting
  • Duke University Medical CenterDurham, United StatesActive, not recruiting
  • University of Cincinnati Cancer CenterCincinnati, United StatesActive, not recruiting
  • Taylor Cancer Research CenterMaumee, United StatesActive, not recruiting
  • SCRI Oncology PartnersNashville, United StatesActive, not recruiting
  • SCRI - Texas Oncology DallasDallas, United StatesActive, not recruiting
  • MD Anderson Cancer CenterHouston, United StatesActive, not recruiting
  • Huntsman Cancer InstituteSalt Lake City, United StatesActive, not recruiting
  • Virginia Cancer SpecialistsFairfax, United StatesActive, not recruiting
  • Virginia Mason Medical CenterSeattle, United StatesActive, not recruiting
  • St. George HospitalKogarah, AustraliaRecruiting
  • Prince of Wales HospitalRandwick, AustraliaRecruiting
  • Calvary Mater NewcastleWaratah, AustraliaRecruiting
  • Royal Brisbane and Women's HospitalHerston, AustraliaRecruiting

And 57 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

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