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NCT03343301 · ClinicalTrials.gov registry record · Phase 1
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer
A Phase 1 study, sponsored by Five Prime Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03343301: Completed Phase 1 study, sponsored by Five Prime Therapeutics.
NCT03343301 is a Phase 1 study that has completed, run by Five Prime Therapeutics. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03343301, a Phase 1 study, has completed, sponsored by Five Prime Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The primary objective of the phase 1 portion of this study is to determine the recommended dose of bemarituzumab in combination with 5-fluorouracil, leucovorin and oxaliplatin (modified FOLFOX6) to use in the phase 2 portion of the trial.
Primary Outcome
A treatment-related adverse event (TRAE) is defined as an adverse event (AE) with an onset date on or after the date of first dose of study treatment, or an event present before treatment that worsened after treatment, and with an onset date prior to 28 days after the last date of dose, for which the investigator assessed as related to investigational product The investigator classified the severity of each AE using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-C
Interventions
- DRUG Modified FOLFOX6
- BIOLOGICAL Bemarituzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-11-30 |
| Est. Completion | 2019-01-31 |
| Phase | Phase 1 |
What the finished NCT03343301 record still lists
NCT03343301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Modified FOLFOX6 is the first listed.
NCT03343301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03343301 about?
NCT03343301 is a clinical study titled "A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer". The primary objective of the phase 1 portion of this study is to determine the recommended dose of bemarituzumab in combination with 5-fluorouracil, leucovorin and oxaliplatin (modified FOLFOX6) to use in the phase 2 portion of the trial.
What is the current status of trial NCT03343301?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-11-30. Estimated completion is 2019-01-31.
What interventions are being tested in trial NCT03343301?
The interventions under investigation include: Modified FOLFOX6 (DRUG), Bemarituzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03343301?
This trial is sponsored by Five Prime Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03343301's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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