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NCT03109158 · ClinicalTrials.gov registry record · Phase 1
NC-6004 With 5-FU and Cetuximab for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study, sponsored by NanoCarrier Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03109158: Completed Phase 1 study, sponsored by NanoCarrier Co..
NCT03109158 is a Phase 1 study that has completed, run by NanoCarrier Co.. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03109158, a Phase 1 study, has completed, sponsored by NanoCarrier Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Part 1 of this study will establish a recommended Phase II (RPII) dose for the triplet combination of NC-6004 plus 5-Fluorouracil (5-FU) and cetuximab. Part 2 will provide the efficacy signal of the triplet combination in this patient population.
Primary Outcome
Part 1: To determine dose limiting toxicities and the RPII dose
Interventions
- DRUG Cetuximab
- DRUG 5-FU
- DRUG NC-6004
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2019-03-01 |
| Phase | Phase 1 |
What the finished NCT03109158 record still lists
NCT03109158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.
NCT03109158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03109158 about?
NCT03109158 is a clinical study titled "NC-6004 With 5-FU and Cetuximab for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck". Part 1 of this study will establish a recommended Phase II (RPII) dose for the triplet combination of NC-6004 plus 5-Fluorouracil (5-FU) and cetuximab. Part 2 will provide the efficacy signal of the triplet combination in this patient population.
What is the current status of trial NCT03109158?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2017-03-01. Estimated completion is 2019-03-01.
What interventions are being tested in trial NCT03109158?
The interventions under investigation include: Cetuximab (DRUG), 5-FU (DRUG), NC-6004 (DRUG).
Who is sponsoring clinical trial NCT03109158?
This trial is sponsored by NanoCarrier Co., which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03109158's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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