Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma (RASolute 303)

Revolution Medicines

Status and phase: Enrolling; Phase 3

Conditions: Pancreatic Cancer Metastatic; Pancreatic Adenocarcinoma Metastatic; PDAC - Pancreatic Ductal Adenocarcinoma; PDAC; Pancreatic Adenocarcinoma; Pancreatic Adenosquamous Carcinoma; Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Cancer

Treatments: Drug: daraxonrasib; Drug: nab-paclitaxel; Drug: gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07491445

RMC-6236-303

Details and patient eligibility

About

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.

Full 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).

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 3 patient groups

Arm A: daraxonrasib

Experimental group

Description:

study drug

Treatment:

Drug: daraxonrasib

Arm B: daraxonrasib + gemcitabine and nab-paclitaxel

Experimental group

Description:

study drug in combination with chemotherapy

Treatment:

Drug: gemcitabine

Drug: nab-paclitaxel

Drug: daraxonrasib

Arm C: gemcitabine and nab-paclitaxel

Active Comparator group

Description:

SOC chemotherapy

Treatment:

Drug: gemcitabine

Drug: nab-paclitaxel