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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: Active Phase 3 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by Amgen.
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. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
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 |
What the registry record for NCT05052801 still lists
NCT05052801 is an interventional study that assigns participants to a tested intervention. The registered 547 participants enrollment target is mid-sized for trials with a published cap, above the 316-participant average among 153 other Gastric Cancer trials with a reported enrollment target (73% higher).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05052801's enrollment target sits among peer trials
547 20th of 153 higher than 134 of 153 other Gastric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric 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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