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NCT04091867 · ClinicalTrials.gov registry record · Phase 1

sEphB4-HSA With RT+Chemo or Cetux in Patients With Intermediate to High Risk LAHNSCC

A Phase 1 study of Squamous Cell Carcinoma of Head and Neck, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 1
Development phase
3
Enrollment target
1
Study location

NCT04091867: Completed Phase 1 study of Squamous Cell Carcinoma of Head and Neck, sponsored by University of Colorado, Denver.

NCT04091867 is a Phase 1 study of Squamous Cell Carcinoma of Head and Neck that has completed, run by University of Colorado, Denver. The registered enrollment target is 3 participants, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04091867, a Phase 1 study of Squamous Cell Carcinoma of Head and Neck, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 1
Development phase
3 participants
Enrollment target
1
Study location

Study Summary

This is a Phase I dose-escalation study of sEphB4-HSA in combination with chemotherapy, cetuximab and radiotherapy (RT). The purpose is to estimate the maximum tolerated dose (MTD) that can be administered concurrently with Cetuximab and radiation in patients with locally advanced, Stage III or IV A-B squamous cell carcinomas of the head or neck with a history of at least ten pack-years of smoking.

Primary Outcome

Severe cetuximab-associated rash is defined as per Lacouture 2010 criteria69, namely \> 20 papules or pustules OR \> 5 areas of erythema or edema \< 1 cm (this is grade 3A) or \> 20 papules/pustules OR \> 5 areas of erythema or edema \< 1 cm AND pain, pruritus, or effect on emotions or functioning (this is a commonly used criteria for grading of rash specifically related to EGFR inhibitors, such as cetuximab).

Conditions Studied

Squamous Cell Carcinoma of Head and Neck

Interventions

  • RADIATION Radiation Therapy
  • DRUG Cetuximab
  • DRUG sEphB4-HSA with chemotherapy

Study Locations (1)

Colorado

  • University of Colorado Hospital - Aurora

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2020-01-06
Est. Completion 2022-10-25
Phase Phase 1
University of Colorado, Denver

1,283 total trials

What the finished NCT04091867 record still lists

NCT04091867 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.

NCT04091867 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT04091867 about?

NCT04091867 is a clinical study titled "sEphB4-HSA With RT+Chemo or Cetux in Patients With Intermediate to High Risk LAHNSCC". This is a Phase I dose-escalation study of sEphB4-HSA in combination with chemotherapy, cetuximab and radiotherapy (RT). The purpose is to estimate the maximum tolerated dose (MTD) that can be administered concurrently with Cetuximab and radiation in patients with locally advanced, Stage III or IV A...

What is the current status of trial NCT04091867?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2020-01-06. Estimated completion is 2022-10-25.

What conditions does trial NCT04091867 study?

This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck.

What interventions are being tested in trial NCT04091867?

The interventions under investigation include: Radiation Therapy (RADIATION), Cetuximab (DRUG), sEphB4-HSA with chemotherapy (DRUG).

Who is sponsoring clinical trial NCT04091867?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04091867 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Squamous Cell Carcinoma of Head and Neck

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 NCT04091867's enrollment target sits among peer trials

3 38th of 37 the lowest of 37 other Squamous Cell Carcinoma of Head and Neck trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of Head and Neck 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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Related registry views

Source: ClinicalTrials.gov NCT04091867, the US trial registry maintained by the National Library of Medicine. NCT04091867 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.