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

Completed · Phase 1/Phase 2

Conditions studied: Carcinoma, Squamous Cell of Head and Neck

In brief

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.

Key facts

Study ID

NCT03109158

Run by

NanoCarrier Co., Ltd.

People needed

1

Starts

2017-03-01

Expected to finish

2019-03-01

Last updated by the study team

2019-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Center — Detroit, Michigan, United States
• Intermountain Precision Genomics — Billings, Montana, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Complex Oncology Center - Shumen EOOD — Shumen, Bulgaria
• Multiprofile Hospital for Active Treatment Serdika EOOD — Sofia, Bulgaria
• Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz — Nyíregyháza, Hungary
• Pecsi Tudomanyegyetem — Pécs, Hungary
• Tolna Megyei Balassa Janos Korhaz — Szekszárd, Hungary
• Coltea Clinical Hospital — Bucharest, Romania
• Prof Dr I Chiricuta Institute of Oncology — Cluj-Napoca, Romania
• Oncology Center Sfantul Nectarie — Craiova, Romania
• Euroclinic Oncology Center SRL — Iași, Romania
• Institutul Regional de Oncologie Iasi — Iași, Romania

Full record on ClinicalTrials.gov

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