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

NCT ID: NCT03109158

Last Updated: 2019-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-03-01

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.

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.

Conditions

Carcinoma, Squamous Cell of Head and Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NC-6004

Intervention Type: DRUG

NC-6004 provided by NanoCarrier

Cetuximab

Intervention Type: DRUG

Commercially Available

5-FU

Intervention Type: DRUG

Commercially Available

Interventions

NC-6004

NC-6004 provided by NanoCarrier

Intervention Type: DRUG

Cetuximab

Commercially Available

Intervention Type: DRUG

5-FU

Commercially Available

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NanoCarrier Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Atsushi Osada, Study Director

Role: STUDY_DIRECTOR

NanoCarrier Co., Ltd.

Locations

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

Countries

United States; Bulgaria; Hungary; Romania

Other Identifiers

NC-6004-008

Identifier Type: -

Identifier Source: org_study_id