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

NCT03109158 | Completed Phase 1 FDA Drug

• 1 other identifier: NC-6004-008
• Study Type: interventional
• Target: 1
• Locations: 4 countries
• Sites: 20

Brief 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

Keywords

squamous cell carcinoma; head; neck

Outcome Measures

Primary Outcomes (2)

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

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

  Up to day 90

• 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.

  Up to day 90

Secondary Outcomes (3)

• Overall response rate

  Up to day 90

• EORTC QLQ-C30

  Up to day 90

• QLQ-Head and Neck 35

  Up to day 90

Other Outcomes (2)

• Incidence and severity of AEs and laboratory abnormalities

  Up to day 90

• Occurrence of SAEs and treatment discontinuations due to AEs

  Up to day 90

Study Arms (1)

NC-6004 and 5-FU

EXPERIMENTAL

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.

Drug: NC-6004; Drug: Cetuximab; Drug: 5-FU

Interventions

NC-6004 DRUG

NC-6004 provided by NanoCarrier

NC-6004 and 5-FU

Cetuximab DRUG

Commercially Available

NC-6004 and 5-FU

5-FU DRUG

Commercially Available

NC-6004 and 5-FU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• NanoCarrier Co., Ltd.: lead

Study Sites (20)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322-1013, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Barbara Ann Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Intermountain Precision Genomics

Billings, Montana, 84107, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235-7320, United States

Location

Complex Oncology Center - Shumen EOOD

Shumen, 9700, Bulgaria

Location

Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, 1618, Bulgaria

Location

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Pecsi Tudomanyegyetem

Pécs, 7624, Hungary

Location

Tolna Megyei Balassa Janos Korhaz

Szekszárd, 7100, Hungary

Location

Coltea Clinical Hospital

Bucharest, Romania

Location

Prof Dr I Chiricuta Institute of Oncology

Cluj-Napoca, 400015, Romania

Location

Oncology Center Sfantul Nectarie

Craiova, 200347, Romania

Location

Euroclinic Oncology Center SRL

Iași, 700106, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Interventions

demplatin pegraglumer; Cetuximab; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Atsushi Osada, Study Director

  NanoCarrier Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open-Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 12, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 29, 2019

Record last verified: 2018-12

Locations

HU (3); BU (2); RO (5); US (10)