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NCT06109467 · ClinicalTrials.gov registry record · Phase 2
Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer
A Phase 2 study of Gastric Cancer and GastroEsophageal Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06109467: Recruiting Phase 2 study of Gastric Cancer and GastroEsophageal Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06109467 is a Phase 2 study of Gastric Cancer and GastroEsophageal Cancer that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 36 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06109467, a Phase 2 study of Gastric Cancer and GastroEsophageal Cancer, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to test the effects, both good and bad, of the research study drug Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX chemotherapy. This study will also look at the safety of Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX in HER2 overexpressing Gastroesophageal cancers.
Primary Outcome
ORR is defined as the best overall response as complete response (CR) + partial response (PR) per RECIST v1.1 criteria. As per RECIST 1.1 criteria, any evidence of response in measurable lesions will be counted toward the calculation of ORR.ORR will be calculated through exact binomial distribution with a 2-sided 95% CI among patients who obtain at least one dose of study drug.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Trastuzumab
- DRUG Oxaliplatin
- DRUG Neratinib
- DRUG 5-Fluorouracil + leucovorin
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-01-12 |
| Est. Completion | 2028-04 |
| Phase | Phase 2 |
What NCT06109467 shows while recruiting
NCT06109467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06109467 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06109467 about?
NCT06109467 is a clinical study titled "Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer". The purpose of the study is to test the effects, both good and bad, of the research study drug Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX chemotherapy. This study will also look at the safety of Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX in HER2 over...
What is the current status of trial NCT06109467?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2024-01-12. Estimated completion is 2028-04.
What conditions does trial NCT06109467 study?
This clinical trial studies the following conditions: Gastric Cancer, GastroEsophageal Cancer.
What interventions are being tested in trial NCT06109467?
The interventions under investigation include: Pembrolizumab (DRUG), Trastuzumab (DRUG), Oxaliplatin (DRUG), Neratinib (DRUG), 5-Fluorouracil + leucovorin (DRUG).
Who is sponsoring clinical trial NCT06109467?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06109467 being conducted?
This trial has 1 study location across Florida. 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 NCT06109467's enrollment target sits among peer trials
36 135th of 153 higher than 19 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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