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NCT05052801 · ClinicalTrials.gov registry record · Phase 3
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
A Phase 3 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by Amgen.
- Active
- Registry status
- Phase 3
- Development phase
- 547
- Enrollment target
- 20
- Study locations
NCT05052801 is a Phase 3 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma that is active but no longer recruiting, run by Amgen. The registered enrollment target is 547 participants, above the 316-participant average among 153 other Gastric Cancer trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT05052801, a Phase 3 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 547 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bemarituzumab
- DRUG mFOLFOX6
Study Locations (20)
California
- The Oncology Institute Clinical Research - Cerritos
- University of California Los Angeles - Los Angeles
New York
- Healthier Hematology and Oncology Excelsior Integrated Medical Group - Brooklyn
- White Plains Hospital Center for Cancer Care - White Plains
North Carolina
- Levine Cancer Institute University - Charlotte
- FirstHealth Cancer Center - Pinehurst
Buenos Aires
- Instituto Alexander Fleming - CABA
- Hospital Universitario Fundacion Favaloro - Ciudad Autonoma de Buenos Aires
Córdoba Province
- Sociedad de Beneficencia Hospital Italiano - Córdoba
- Hospital Privado Universitario de Cordoba - Córdoba
Alaska
- Alaska Oncology and Hematology - Anchorage
Arizona
- Mayo Clinic Arizona - Phoenix
Florida
- Mayo Clinic Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 547 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2026-06-20 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05052801
The ClinicalTrials.gov registry entry for NCT05052801 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 547 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 316-participant average among 153 other Gastric Cancer trials with a reported enrollment target (73% higher). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05052801 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05052801 about?
NCT05052801 is a clinical study titled "Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression". The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)
What is the current status of trial NCT05052801?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 547 participants. The study started on 2022-03-07. Estimated completion is 2026-06-20.
What conditions does trial NCT05052801 study?
This clinical trial studies the following conditions: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma.
What interventions are being tested in trial NCT05052801?
The interventions under investigation include: Placebo (DRUG), Bemarituzumab (DRUG), mFOLFOX6 (DRUG).
Who is sponsoring clinical trial NCT05052801?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05052801 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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