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Carcinoma, Squamous Cell of Head and NeckPhase 1/2NCT03109158

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

A Phase 1/2 study testing NC-6004, Cetuximab and 5-FU in people with Carcinoma, Squamous Cell of Head and Neck, run by NanoCarrier Co., Ltd. at 20 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NC-6004, Cetuximab and 5-FU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
20 sitesin 4 countries
Study dates
1 Mar 2017to 1 Mar 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck not suited for local therapy
  • Measurable disease, as defined by RECIST v1.1
  • ECOG performance status 0-1
  • Adequate bone marrow reserve
  • Adequate liver and renal function
  • Have a negative pregnancy test result at Screening for females of childbearing potential
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  • Male patients must agree to use a condom during treatment and for 90 days after dosing and must agree not to donate sperm for 90 days after dosing
  • Women of childbearing potential are willing to agree to use 1 of the study-defined effective methods of birth control from the time of study entry to 6 months after the last day of treatment
  • Reasonably recovered from preceding major surgery as judged by the investigator or no major surgery within 4 weeks prior to the start of Day 1 treatment

Who cannot join

  • Nasopharyngeal carcinoma
  • Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 3 months before Day 1 or more than 6 months prior to Day 1 if platinum-based
  • Concomitant anticancer therapy, systemic immune therapy, or hormonal therapy as cancer therapy
  • Unresolved toxicity from all radiation, adjuvant/ neoadjuvant chemotherapy, other targeted treatment including investigational treatment
  • History of thrombocytopenia with complications
  • Known hypersensitivity to platinum compounds
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  • Pregnant or breastfeeding
  • Active infection (infection requiring intravenous antibiotics)
  • Uncontrolled hypertension
  • Malignancies other than head and neck cancer within 5 years prior to Day 1 of treatment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • Signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol
  • Have experienced any of the following within the 6-month period prior to Screening: unstable angina pectoris, clinically significant coronary artery disease, cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia
  • Any investigational treatment within 30 days or 5 half-lives, whichever is longer, of Day 1 of treatment
  • Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the treatment phase of the study without prior consent from the medical monitor
  • Any other medical or social condition that, in the opinion of the investigator, would not permit the patient to complete the study or sign informed consent

Trial locations and contacts

20 sites in 4 countries.

20 sites in 4 countries

United States10 sites

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322-1013

  • Intermountain Precision Genomics

    Billings, Montana, 84107

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235-7320

  • Barbara Ann Karmanos Cancer Center

    Detroit, Michigan, 48201

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

Romania5 sites

  • Coltea Clinical Hospital

    Bucharest

  • Prof Dr I Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Oncology Center Sfantul Nectarie

    Craiova, 200347

  • Euroclinic Oncology Center SRL

    Iași, 700106

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

Other trials in Romania

Hungary3 sites

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • Pecsi Tudomanyegyetem

    Pécs, 7624

  • Tolna Megyei Balassa Janos Korhaz

    Szekszárd, 7100

Other trials in Hungary

Bulgaria2 sites

  • Complex Oncology Center - Shumen EOOD

    Shumen, 9700

  • Multiprofile Hospital for Active Treatment Serdika EOOD

    Sofia, 1618

Other trials in Bulgaria

About this study

Official title: Phase I/II Clinical Trial of NC-6004 in Combination With 5-FU and Cetuximab as First-line Treatment in Patients With 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.

Read the detailed description

NC-6004 is a polymeric micelle-containing cisplatin as an active moiety. The nanoparticle provides sustained release of the active moiety and utilizes the enhanced permeability and retention effect to target release of platinum to tumors. Currently available nonclinical data and enhanced pharmacokinetics suggest that NC-6004 has the potential to be more active than cisplatin, with increased tolerability.

Being tested
NC-6004, Cetuximab, 5-FU
Keywords
squamous cell carcinoma, head, neck
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NC-6004Drug

    NC-6004 provided by NanoCarrier

  • CetuximabDrug

    Commercially Available

  • 5-FUDrug

    Commercially Available

Study groups in NCT03109158
Study groupRoleWhat they receive
NC-6004 and 5-FUExperimentalPhase I, continual reassessment method, dose-escalation study to determine the maximum tolerated dose (MTD) and an RPII dose of NC-6004 in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. In Part 1, patients will be assigned to receive cetuximab followed by NC-6004 and 5-FU. Phase II, adaptive, open-label expansion study evaluating the activity, safety, and tolerability of NC-6004 in patients with recurrent or metastatic squamous cell carcinoma of the head and neck at the RPII dose identified in Part 1. In Part 2, all patients will receive NC-6004 at the RPII dose established in Part 1, in combination with cetuximab and 5-FU according to the same schedule as used in Part 1.
Receives: Drug: NC-6004; Drug: Cetuximab; Drug: 5-FU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RPII dose for the combination of NC-6004 plus 5-FU plus cetuximab.

    Part 1: To determine dose limiting toxicities and the RPII dose

    Measured: Up to day 90

  2. Progression free survival in patients following treatment with NC-6004 plus 5-FU plus cetuximab.

    Part 2: To determine the median PFS in patients with recurrent or metastatic squamous cell carcinoma of the head and neck after treatment with NC-6004 plus cetuximab plus 5-FU.

    Measured: Up to day 90

Secondary outcomes (3)

  1. Overall response rate

    To evaluate overall response rate (ORR), duration of response (DOR), disease control rate (DCR = complete response [CR] + partial response [PR] +stable disease), duration of stable disease (DSD), and overall survival (OS).

    Measured: Up to day 90

  2. EORTC QLQ-C30

    Least squares mean estimates for health-related quality of life (HRQOL) scores over time

    Measured: Up to day 90

  3. QLQ-Head and Neck 35

    Least squares mean estimates for health-related quality of life (HRQOL) scores over time

    Measured: Up to day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start1 Mar 2017
  3. Primary completion1 Mar 2019
  4. Study completion1 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03109158
Sponsor's protocol ID
NC-6004-008
Status last verified
Dec 2018
First submitted
22 Mar 2017
Last updated
29 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NC-6004, Cetuximab and 5-FU in people with Carcinoma, Squamous Cell of Head and Neck, run by NanoCarrier Co., Ltd. at 20 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Romania, Hungary, Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RPII dose for the combination of NC-6004 plus 5-FU plus cetuximab. (time frame: Up to day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03109158.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.

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