- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03109158
NC-6004 With 5-FU and Cetuximab for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Shumen, Bulgaria, 9700
- Complex Oncology Center - Shumen EOOD
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Sofia, Bulgaria, 1618
- Multiprofile Hospital for Active Treatment Serdika EOOD
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Nyíregyháza, Hungary, 4400
- Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
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Pécs, Hungary, 7624
- Pecsi Tudomanyegyetem
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Szekszárd, Hungary, 7100
- Tolna Megyei Balassa János Kórház
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Bucharest, Romania
- Coltea Clinical Hospital
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Cluj-Napoca, Romania, 400015
- Prof Dr I Chiricuta Institute of Oncology
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Craiova, Romania, 200347
- Oncology Center Sfantul Nectarie
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Iaşi, Romania, 700106
- Euroclinic Oncology Center SRL
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Iaşi, Romania, 700483
- Institutul Regional de Oncologie Iasi
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California
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
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Georgia
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Atlanta, Georgia, United States, 30322-1013
- Winship Cancer Institute, Emory University
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Center
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Montana
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Billings, Montana, United States, 84107
- Intermountain Precision Genomics
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- The University of Oklahoma Health Sciences Center
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Texas
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Dallas, Texas, United States, 75235-7320
- University of Texas Southwestern Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: NC-6004 and 5-FU
Phase 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. |
NC-6004 provided by NanoCarrier
Commercially Available
Commercially Available
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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RPII dose for the combination of NC-6004 plus 5-FU plus cetuximab.
Time Frame: Up to day 90
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Part 1: To determine dose limiting toxicities and the RPII dose
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Up to day 90
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Progression free survival in patients following treatment with NC-6004 plus 5-FU plus cetuximab.
Time Frame: Up to day 90
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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.
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Up to day 90
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: Up to day 90
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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).
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Up to day 90
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EORTC QLQ-C30
Time Frame: Up to day 90
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Least squares mean estimates for health-related quality of life (HRQOL) scores over time
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Up to day 90
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QLQ-Head and Neck 35
Time Frame: Up to day 90
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Least squares mean estimates for health-related quality of life (HRQOL) scores over time
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Up to day 90
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence and severity of AEs and laboratory abnormalities
Time Frame: Up to day 90
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Incidence and severity of AEs and laboratory abnormalities, according to the NCI CTCAE v4.03 criteria.
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Up to day 90
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Occurrence of SAEs and treatment discontinuations due to AEs
Time Frame: Up to day 90
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Adverse events will be summarized by dose level, in subsets of all TEAEs, and by all treatment-related AEs.
Clinical laboratory and vital sign measurements will be summarized by dose level and change from baseline.
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Up to day 90
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Atsushi Osada, Study Director, NanoCarrier Co., Ltd.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NC-6004-008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Squamous Cell of Head and Neck
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Washington University School of MedicineMerck Sharp & Dohme LLCActive, not recruitingHead and Neck Cancer | Squamous Cell Carcinoma of the Head and Neck | Cancer of Head and Neck | Carcinoma, Squamous Cell of Head and Neck | Neoplasms, Head and Neck | Squamous Cell Carcinoma, Head and NeckUnited States
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Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Advanced Head and Neck Squamous Cell Carcinoma | Metastatic Head-and-neck Squamous-cell Carcinoma | Locally Advanced Head and Neck Squamous Cell Carcinoma | Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck | Stage IV Cutaneous...United States
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University of PittsburghNational Cancer Institute (NCI)TerminatedSquamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma, Head And Neck | Carcinoma, Squamous Cell of Head and NeckUnited States
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Eben RosenthalNational Cancer Institute (NCI)CompletedHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN)United States
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Arnaud Bewley, MDNational Cancer Institute (NCI); Genentech, Inc.TerminatedStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck | Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and NeckUnited States
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Washington University School of MedicineActive, not recruitingSquamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma, Head and NeckUnited States
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James J LeeAVEO Pharmaceuticals, Inc.CompletedSquamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma, Head And Neck | Carcinoma, Squamous Cell of Head and NeckUnited States
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