- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02817113
Study of NC-6004 in Combination With 5-FU and Cetuximab in Patients With Head and Neck Cancer
April 29, 2021 updated by: Orient Europharma Co., Ltd.
Phase I Study of NC-6004 in Combination With 5-FU and Cetuximab as First-line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
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 (EPR) effect to target release of platinum to tumors.
This Phase I study aims to establish a recommended dose (RD) for the triplet combination of NC-6004 plus 5-FU and cetuximab as first-line treatment in patient with recurrent and/or metastatic squamous cell carcinoma of the head and neck for further clinical study development.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Primary objectives
♦ To determine the Maximum Tolerated Dose (MTD) of NC-6004 according to the Dose Limiting Toxicity (DLT) in combination with 5-FU plus cetuximab as firstline treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), and to decide the RD for the following studies
- Secondary objectives 1). To evaluate the safety and tolerability profile of NC-6004 in combination with 5- FU plus cetuximab 2). To assess the pharmacokinetic effects of NC-6004 3). To assess the antitumor effects of NC-6004
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital, Linkou Branch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed written informed consent
- Known (histology/cytology proven) or evidenced by radiology of recurrent and/or metastatic SCCHN not suited for local therapy
- Males or females aged ≥ 20 years and < 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy >12 weeks as judged by investigators
- Adequate bone marrow reservation:
- Adequate liver function:
- Adequate renal function:
- 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:
- Female of child-bearing potential who is or has intention to be pregnant or breastfeeding.
- Previous radiotherapy within 3 months before study entry
- Known brain metastasis or leptomeningeal involvement
- Marked pleural effusion or ascites above Grade 2, based on NCI-CTCAE v4.03 criteria
- History of thrombocytopenia with complications (including hemorrhage or bleeding ≥ Grade 2, based on NCI-CTCAE v4.03 criteria), hemolytic condition, or coagulation disorders that would make subjects unsafe based on the judgment of the Investigator
- Patients who have unresolved toxicity from all radiation, adjuvant/neoadjuvant chemotherapy, other targeted treatment including investigational treatment (exception of alopecia and ≤ Grade 2 peripheral neuropathy) according to NCI-CTCAE v4.03 criteria
- Known hypersensitivity to the study drugs or the drugs with similar chemical structures
- History of myocardial infarction within 6 months before study entry, unstable congestive heart failure (New York Heart Association, NYHA Stage III-IV), angina pectoris, or transient ischemic attack or cardiac arrhythmia requiring medical therapy
- History of any other cancer other than head and neck cancer (HNC) (except carcinoma in situ of the cervix) within the last 5 years.
- Primary tumor of the nasopharynx (nasopharyngeal carcinoma)
- Known HIV-1 or any active infection requiring IV antibiotics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: NC-6004, Cetuximab and 5-FU
Cetuximab will be administered before the start of chemotherapy at a loading dose of 400 mg/m2 given, followed by a subsequent weekly doses of 250 mg/m2; NC-6004 will be administered on Day 1 every 3 weeks, and 5-FU will be administered at a dose of 1,000 mg/m2/day on Day 1- Day 4 as continuous infusion every 3 weeks.
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One cycle of treatment lasts for 3 weeks.
NC-6004 will be administered over 1 hour on Day 1 (after the cetuximab infusion) every 3 weeks
Other Names:
One cycle of treatment lasts for 3 weeks.
For each cycle, cetuximab will be administered at least 1 hour before the start of chemotherapy at a loading dose of 400 mg/m2 given over 2 hours initially (ie, on the first day of treatment), followed by a subsequent weekly doses of 250 mg/m2 over 1 hour.
Other Names:
One cycle of treatment lasts for 3 weeks.
5-FU will be administered at a dose of 1,000 mg/m2/day on Day 1- Day 4 as continuous infusion every 3 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD)
Time Frame: 29 months
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MTD of NC-6004 according to the DLT when administered in combination with 5-FU plus cetuximab as first-line treatment
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29 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 29 months
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According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 criteria
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29 months
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Incidence of AE lead to treatment discontinuation
Time Frame: 29 months
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29 months
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Peak Plasma Concentration (Cmax)
Time Frame: Within 4 cycles (each cycle is 21 days)
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Within 4 cycles (each cycle is 21 days)
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Time of Maximum concentration observed (Tmax)
Time Frame: Within 4 cycles (each cycle is 21 days)
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Within 4 cycles (each cycle is 21 days)
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Area under the plasma concentration-time curve from time zero to time (AUC0-t)
Time Frame: Within 4 cycles (each cycle is 21 days)
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Within 4 cycles (each cycle is 21 days)
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Area under the concentration time-curves from time zero to infinity (AUC0-∞)
Time Frame: Within 4 cycles (each cycle is 21 days)
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Within 4 cycles (each cycle is 21 days)
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Terminal Elimination Rate Constant (λz)
Time Frame: Within 4 cycles (each cycle is 21 days)
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Within 4 cycles (each cycle is 21 days)
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Elimination Half-life (t½)
Time Frame: Within 4 cycles (each cycle is 21 days)
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Within 4 cycles (each cycle is 21 days)
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Clearance (CL) of total platinum in plasma
Time Frame: Within 4 cycles (each cycle is 21 days)
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Within 4 cycles (each cycle is 21 days)
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Clearance (CL) of total platinum in plasma ultrafiltrate
Time Frame: Within 4 cycles (each cycle is 21 days)
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Within 4 cycles (each cycle is 21 days)
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Volume of Distribution (Vz) of total platinum in plasma
Time Frame: Within 4 cycles (each cycle is 21 days)
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Within 4 cycles (each cycle is 21 days)
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Volume of Distribution (Vz) of total platinum in plasma ultrafiltrate
Time Frame: Within 4 cycles (each cycle is 21 days)
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Within 4 cycles (each cycle is 21 days)
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Tumor response rate (RR)
Time Frame: 29 months
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Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results
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29 months
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Disease control rate (DCR)
Time Frame: 29 months
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Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results
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29 months
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Overall response rate (ORR)
Time Frame: 29 months
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Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results
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29 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Changes in vital signs
Time Frame: 29 months
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Arterial blood pressure, heart rate, respiratory rate and temperature are to be monitored during infusion.
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29 months
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Changes in laboratory results
Time Frame: 29 months
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Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
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29 months
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Physical examination findings
Time Frame: 29 months
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Number of participants with physical examination abnormal findings that are related to treatment.
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29 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ruey-Long Hong, MD PhD, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
June 6, 2016
First Submitted That Met QC Criteria
June 24, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Actual)
April 30, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Fluorouracil
- Cetuximab
Other Study ID Numbers
- NC-6004-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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