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NC-6004 With 5-FU and Cetuximab for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT03109158 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-04-29

No results posted yet for this 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.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck

Interventions

DRUG

NC-6004

NC-6004 provided by NanoCarrier

DRUG

Cetuximab

Commercially Available

DRUG

5-FU

Commercially Available

Sponsors & Collaborators

  • NanoCarrier Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Atsushi Osada, Study Director · NanoCarrier Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-03-01
Completion
2019-03-01
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Hungary
  • Romania

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109158 on ClinicalTrials.gov