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Study details
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A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Astellas Pharma Global Development, Inc.
NCT IDNCT07409272ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Ages

18+

Locations

12 sites in CA, FL, KY +5

What this study is about

This Phase 3 study is testing Irinotecan in people with pancreatic adenocarcinoma. The primary outcome being measured is Overall Survival (OS).

Simplified from trial records by PatientMatch.

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IVInjection / IV

How treatment is administered

Treatment Assignment
Standard assignment

Assignment is predetermined by the study protocol.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

irinotecan, Antidotes, Deterrents, and Toxicologic Agents (Enzyme Interactions), oxaliplatin, fluorouracil (Antimetabolite; mimics uracil to disrupt DNA/RNA in cancer cells)

Drug routes

injection (Injection), oral (Oral Capsule)

Endpoints

Primary: Overall Survival (OS)

Secondary: Change from baseline in EORTC QLQ-C30, Change from baseline in EORTC QLQ-PAN26, Change from baseline in EuroQol 5-dimensional 5-level version (EQ-5D-5L), Change from baseline in Patient Global Impression of Change (PGIC)., Change from baseline in Patient Global Impression of Severity PGIS, Number of Participants with Adverse Events (AEs), Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status., Number of Participants with Serious Adverse Events (SAEs)

Body systems

Oncology