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

Conditions

• PDAC
• PDAC - Pancreatic Ductal Adenocarcinoma
• Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RMC-6236 — DRUG
  Oral Tablets
• Gemcitabine — DRUG
  intravenous (IV) infusion
• nab-paclitaxel — DRUG
  IV infusion
• Irinotecan — DRUG
  IV infusion
• Liposomal irinotecan — DRUG
  IV infusion
• 5-fluorouracil — DRUG
  IV infusion
• leucovorin — DRUG
  IV infusion
• Oxaliplatin — DRUG
  IV infusion

Study Details

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.

Key Dates

Start date

Oct 16, 2024

Status verified

Nov 2025

Primary completion

Jun 30, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

500 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: RMC-6236
  Study drug
• Active Comparator: Investigator's choice of standard of care therapy
  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)

Primary Outcome Measure

Progression free survival (PFS) in the RAS G12-mutant population [ Time Frame: Up to approximately 3 years ]

Locations (37)

Find similar trials in Gilbert, AZ

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