Home/Loved One/NCT07252232
Phase 3Recruiting
View on ClinicalTrials.gov

Testing daraxonrasib for pancreatic cancer

Official title: Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Condition: Pancreatic CancerSponsor: Revolution Medicines, Inc.Target enrollment: 500
  • Phase 3
  • 2 groups
  • Sites in Toronto and Montreal
  • Recruiting
Princess Margaret Cancer Centre - University Health Network, Toronto, OntarioMcGill University Health Centre, Montreal, Quebec

Interventions

  • Medication

    daraxonrasib

    oral tablets

Canadian Sites (2)

2 of 2 recruiting

  • Princess Margaret Cancer Centre - University Health Network

    Toronto, Ontario

    Recruiting
  • McGill University Health Centre

    Montreal, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for12 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +At least 18 years old and has provided informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
  • +Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • +Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
  • +Must have completed most recent treatment within the past 12 weeks.
  • +Adequate organ function (bone marrow, liver, kidney, coagulation).
  • +Documented RAS mutation status.
  • +Able to take oral medications.
  • +Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.

Exclusion

  • −Any conditions that may affect the ability to take or absorb study drug.
  • −Patient is unable or unwilling to comply with protocolProtocolThe detailed plan a study must follow.Read more →-required study visits or procedures.
  • −Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  • −Major surgery within 28 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives daraxonrasib.

Registry label: A: daraxonrasib

Group B receives no study treatment and is followed for comparison.

Registry label: B: SOC Observation

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment at all, and is followed for comparison.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 500 people.

The study is currently expected to finish around July 2030.

The main measurement is taken over: Up to approximately 5 years.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Disease-Free Survival (DFS) per InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → — measured over Up to approximately 5 years.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07252232 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About daraxonrasibDrug

oral tablets

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment and is followed for comparison.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Up to approximately 5 years.

The study as a whole is currently expected to finish around 2030-07-10.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 500 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 6 locations, including: Toronto, Ontario, Canada; Montreal, Quebec, Canada; Rochester, Minnesota, United States; New York, New York, United States; Rochester, New York, United States; Seattle, Washington, United States.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

Other Sites (7)

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Fred Hutchison Cancer Center

Seattle, Washington, United States

Worth passing on?

Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.

Review the Care Package

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.