NCT06625320|Active Not RecruitingPhase 3DMCFDA Drug

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

RASolute 302

RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of Daraxonrasib (RMC-6236) Versus Investigator's Choice of Standard of Care Therapy in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Revolution Medicines, Inc.ClinicalTrials.gov

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1 other identifier

RMC-6236-302

Study Type

interventional

Target

500

Locations

7 countries

Sites

Timeline

RegisteredOct 2024

StartedOct 2024

CompletionDec 2027

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

500

participants targeted

Target at P50-P75 for phase_3 pancreatic-cancer

Timeline

19mo left

Started Oct 2024

Geographic Reach

7 countries

60 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

Study Progress50%

Oct 2024Dec 2027

First Submitted

Initial submission to the registry

September 20, 2024

Completed

13 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed

13 days until next milestone

Study Start

First participant enrolled

October 16, 2024

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 27, 2026

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

September 20, 2024

Last Update Submit

April 22, 2026

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma PDAC Pancreatic Cancer

Keywords

Pancreatic CancerPDACPancreatic Ductal AdenocarcinomaRASKRASNRASHRASRAS Wild-TypeRAS Q61 MutationRAS G12 MutationRAS G13 Mutation

Outcome Measures

Primary Outcomes (2)

Progression free survival (PFS) in the RAS G12-mutant population
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 blinded independent central review (BICR)
Up to approximately 3 years
Overall survival (OS) in the RAS G12-mutant population
OS is defined as the time from randomization until death from any cause.
Up to approximately 3 years

Secondary Outcomes (10)

PFS in the all-patient population
Up to approximately 3 years
OS in the all-patient population
Up to approximately 3 years
Objective response in the RAS G12 and all-patient populations
Up to approximately 3 years
Time to deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) in the RAS G12 and all-patient populations
Up to approximately 3 years
Time to deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in the RAS G12 and all-patient populations
Up to approximately 3 years
+5 more secondary outcomes

Study Arms (2)

RMC-6236

EXPERIMENTAL

Study drug

Drug: RMC-6236

Investigator's choice of standard of care therapy

ACTIVE COMPARATOR

Patients randomized to Investigator's choice of standard of care chemotherapy will receive one of the following four treatments: * Gemcitabine and nab-paclitaxel (GnP) * Oxaliplatin, leucovorin, irinotecan, and 5-FU (Modified FOLFIRINOX: mFOLFIRINOX) * Liposomal irinotecan (Nal-IRI + 5-FU/LV) * Oxaliplatin, leucovorin and 5-FU IV (FOLFOX)

Drug: GemcitabineDrug: nab-paclitaxelDrug: IrinotecanDrug: Liposomal irinotecanDrug: 5-fluorouracilDrug: leucovorinDrug: Oxaliplatin

Interventions

RMC-6236DRUG

Oral Tablets

RMC-6236

GemcitabineDRUG

intravenous (IV) infusion