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

Carcinoma, Squamous Cell of Head and Neck Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109158
• Other study ID #: NC-6004-008
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: December 2018
• Source: NanoCarrier Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• NC-6004
NC-6004 provided by NanoCarrier
• Cetuximab
Commercially Available
• 5-FU
Commercially Available

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
NanoCarrier Co., Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria,  Hungary,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence and severity of AEs and laboratory abnormalities	Incidence and severity of AEs and laboratory abnormalities, according to the NCI CTCAE v4.03 criteria.	Up to day 90
Other	Occurrence of SAEs and treatment discontinuations due to AEs	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.	Up to day 90
Primary	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
Primary	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	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).	Up to day 90
Secondary	EORTC QLQ-C30	Least squares mean estimates for health-related quality of life (HRQOL) scores over time	Up to day 90
Secondary	QLQ-Head and Neck 35	Least squares mean estimates for health-related quality of life (HRQOL) scores over time	Up to day 90