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

NCT ID: NCT07252232

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2030-07-10

Brief Summary

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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.

Detailed Description

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This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.

Conditions

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Pancreatic Cancer PDAC PDAC - Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Ductal Adenocarcinoma (PDAC) Resected Pancreatic Adenocarcinoma

Keywords

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Pancreatic Cancer PDAC Pancreatic Ductal Adenocarcinoma RAS KRAS NRAS HRAS RAS Wild-Type RASolute Resectable Pancreatic Ductal Adenocarcinoma Resectable PDAC Resected Pancreatic Adenocarcinoma RAS Mutation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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daraxonrasib

study drug

Group Type EXPERIMENTAL

daraxonrasib

Intervention Type DRUG

oral tablets

SOC Observation

Patients randomized to the comparator control arm will receive SOC observation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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daraxonrasib

oral tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old and has provided informed consent.
* 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 received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.
* 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.

Exclusion Criteria

* Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Revolution Medicines, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hartford Healthcare

Hartford, Connecticut, United States

Site Status NOT_YET_RECRUITING

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Site Status RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, United States

Site Status RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Pan American Oncology Trials, LLC

Río Piedras, Puerto Rico, Puerto Rico

Site Status RECRUITING

Countries

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United States Puerto Rico

Central Contacts

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Revolution Medicines Study Director

Role: CONTACT

Phone: 1-844-2-REVMED

Email: [email protected]

Facility Contacts

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Jonathan Steinmetz

Role: primary

Marc Roth

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Other Identifiers

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RMC-6236-304

Identifier Type: -

Identifier Source: org_study_id