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NCT05945823 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
A Phase 2 study of Pancreatic Cancer and Esophageal Adenocarcinoma, sponsored by Taiho Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 20
- Study locations
NCT05945823: Active Phase 2 study of Pancreatic Cancer and Esophageal Adenocarcinoma, sponsored by Taiho Oncology.
NCT05945823 is a Phase 2 study of Pancreatic Cancer and Esophageal Adenocarcinoma that is active but no longer recruiting, run by Taiho Oncology. The registered enrollment target is 53 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05945823, a Phase 2 study of Pancreatic Cancer and Esophageal Adenocarcinoma, is active but no longer recruiting, sponsored by Taiho Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.
Primary Outcome
Defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cisplatin
- DRUG Oxaliplatin
- DRUG 5-FU
- DRUG Futibatinib
Study Locations (20)
Other
- Centre Hospitalier Regional Universitaire de Lille - Lille
- Centre Hospitalier Regional Universitaire Poitiers - Poitiers
- Krankenhaus Nordwest gGmbH - Frankfurt
- Universitaetsmedizin Mainz - Mainz
Florida
- Mount Sinai Comprehensive Cancer Center - Miami Beach
- Moffitt Cancer Center and Research Institute - Tampa
New York
- Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI)) - Buffalo
- NYU Langone - New York
Virginia
- Inova Schar Cancer Institute - Fairfax
- Blue Ridge Cancer Care - Roanoke
California
- University of California Los Angeles UCLA - Cancer Care - Santa Monica - Santa Monica
Colorado
- Rocky Mountain Cancer Centers Midtown - Denver
Michigan
- Henry Ford Health System - Detroit
New Jersey
- The Minniti Center - Medical Oncology and Hematology - Mickleton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2023-07-13 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What the registry record for NCT05945823 still lists
NCT05945823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (87% lower).
The record links to 5 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05945823 names 20 study sites across 14 states, led by Other, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT05945823 about?
NCT05945823 is a clinical study titled "Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors". This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.
What is the current status of trial NCT05945823?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2023-07-13. Estimated completion is 2027-01.
What conditions does trial NCT05945823 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Cancer, Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer, Siewert Type 1 GEJ Cancer.
What interventions are being tested in trial NCT05945823?
The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), Oxaliplatin (DRUG), 5-FU (DRUG), Futibatinib (DRUG).
Who is sponsoring clinical trial NCT05945823?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05945823 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05945823's enrollment target sits among peer trials
53 149th of 278 higher than 130 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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