Clinical Trials List
Protocol NumberNC-6004-006
NCT Number(ClinicalTrials.gov Identfier)NCT02817113
2016-04-01 - 2018-12-04
Phase I
Terminated3
ICD-10C44.42
Squamous cell carcinoma of skin of scalp and neck
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
-
Trial Applicant
Orient EuroPharma Co., Ltd.
-
Sponsor
Orient EuroPharma Co., Ltd.
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
- Chun-Yu Liu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
3 Stop recruiting
Audit
None
Co-Principal Investigator
- Cheng-Lung Hsu Division of Hematology & Oncology
- Tzu-Chen Yen Division of Nuclear Medicine
- Tung-Chieh Chang Division of Radiation Therapy
- Chia-Hsun Hsieh Division of Hematology & Oncology
- Li-Yu Lee Division of Others -
- Chi-Ting Liau Division of Hematology & Oncology
- Shu-Hang Ag Division of Radiology
- 廖俊達 Division of Otolaryngology
The Actual Total Number of Participants Enrolled
1 Stop recruiting
Audit
None
Co-Principal Investigator
- Hsiang-Fong Kao Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
- HUAI-CHENG HUANG Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Objectives
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 for further clinical study
development.
1. 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
2. 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
Test Drug
NC-6004
Active Ingredient
cis-diamminedichloroplatinum(II) polyethylenglycol-polyglutamate polymeric micelles
Dosage Form
Injection
Dosage
5 mL/vial (10 mg/mL Cisplatin)
Endpoints
1. Primary Endpoint:
♦ MTD of NC-6004 according to the DLT when administered in combination with
5-FU plus cetuximab as first-line treatment
2. Secondary Endpoints:
1). Incidence and severity of adverse events (AEs) and serious adverse events
(SAEs), according to National Cancer Institute-Common Terminology Criteria
for Adverse Events (NCI-CTCAE) v4.03 criteria
2). Incidence of AE lead to treatment discontinuation
3). Pharmacokinetics profile, including Cmax, tmax, AUC0-t, AUC0-∞, λz, t½, CL and Vz
of total platinum in plasma and plasma ultrafiltrate
4). Tumor response rate (RR), disease control rate (DCR) and overall response rate
(ORR), assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
criteria version 1.1 on MRI or CT results
3. Safety Endpoints:
1). Changes in vital signs
2). Changes in laboratory results
3). Physical examination findings
4). Mean treatment duration
5). Mean treatment cycle
♦ MTD of NC-6004 according to the DLT when administered in combination with
5-FU plus cetuximab as first-line treatment
2. Secondary Endpoints:
1). Incidence and severity of adverse events (AEs) and serious adverse events
(SAEs), according to National Cancer Institute-Common Terminology Criteria
for Adverse Events (NCI-CTCAE) v4.03 criteria
2). Incidence of AE lead to treatment discontinuation
3). Pharmacokinetics profile, including Cmax, tmax, AUC0-t, AUC0-∞, λz, t½, CL and Vz
of total platinum in plasma and plasma ultrafiltrate
4). Tumor response rate (RR), disease control rate (DCR) and overall response rate
(ORR), assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
criteria version 1.1 on MRI or CT results
3. Safety Endpoints:
1). Changes in vital signs
2). Changes in laboratory results
3). Physical examination findings
4). Mean treatment duration
5). Mean treatment cycle
Inclution Criteria
Main inclusion criteria:
The following are requirements for a patient to enter the study; all criteria must be met
prior to study entry:
1) Signed written informed consent
2) Known (histology/cytology proven) or evidenced by radiology of recurrent and/or
metastatic SCCHN not suited for local therapy
3) Males or females aged ≥ 20 years and < 75 years
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
5) Life expectancy >12 weeks as judged by investigators
6) Adequate bone marrow reservation:
a) absolute neutrophil count (ANC) ≥ 1.5 x 109
/L,
b) platelet count (PLT) ≥ 100 x 109
/L, and
c) hemoglobin (Hb) ≥ 9 g/L
7) Adequate liver function:
a) total serum bilirubin ≤ 1.5 x upper limit of normal (ULN), and
b) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <
2.5 x ULN or ≤ 5.0 x ULN in case of documented hepatic metastasis (ALT,
AST)
8) Adequate renal function:
glomerular filtration rate (GFR) ≥ 50 mL/min (calculated according to the
formula of Cockcroft and Gault)
9) 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
10) Use of a medically accepted form of contraception from the time of consent to
completion of all follow-up study visits.
The following are requirements for a patient to enter the study; all criteria must be met
prior to study entry:
1) Signed written informed consent
2) Known (histology/cytology proven) or evidenced by radiology of recurrent and/or
metastatic SCCHN not suited for local therapy
3) Males or females aged ≥ 20 years and < 75 years
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
5) Life expectancy >12 weeks as judged by investigators
6) Adequate bone marrow reservation:
a) absolute neutrophil count (ANC) ≥ 1.5 x 109
/L,
b) platelet count (PLT) ≥ 100 x 109
/L, and
c) hemoglobin (Hb) ≥ 9 g/L
7) Adequate liver function:
a) total serum bilirubin ≤ 1.5 x upper limit of normal (ULN), and
b) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <
2.5 x ULN or ≤ 5.0 x ULN in case of documented hepatic metastasis (ALT,
AST)
8) Adequate renal function:
glomerular filtration rate (GFR) ≥ 50 mL/min (calculated according to the
formula of Cockcroft and Gault)
9) 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
10) Use of a medically accepted form of contraception from the time of consent to
completion of all follow-up study visits.
Exclusion Criteria
Main exclusion criteria:
Patients will be excluded from study entry if any of the following criteria is met:
1) Female of child-bearing potential who is or has intention to be pregnant or
breastfeeding.
*Absence of pregnancy is to be confirmed by serum/urine human chorionic
gonadotropin (HCG) test
2) Previous radiotherapy within 3 months before study entry
3) Known brain metastasis or leptomeningeal involvement
4) Marked pleural effusion or ascites above Grade 2, based on NCI-CTCAE v4.03
criteria
5) 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
6) 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 NCICTCAE v4.03 criteria
7) Known hypersensitivity to the study drugs or the drugs with similar chemical
structures
8) 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
9) History of any other cancer other than head and neck cancer (HNC) (except
carcinoma in situ of the cervix) within the last 5 years.
10) Primary tumor of the nasopharynx (nasopharyngeal carcinoma)
11) Known HIV-1 or any active infection requiring IV antibiotics
12) Signs or symptoms of organ failure, major chronic illnesses other than cancer, or
any concomitant medical or social conditions which, based on the judgment of the
Investigator, make it undesirable for the subject to participate in the study, or
which could jeopardize compliance with the protocol
13) Patients who are unwilling or unable to comply with study procedures, or are
planning to take vacation for 7 or more consecutive days during the treatment
phase of the study
14) Use of investigational drug or device within 30 days prior to screening
15) Patients who receive prior systemic chemotherapy, except for those given for the
locally advanced disease or (neo)adjuvant therapy completed more than 3 months
prior to study drug treatment
16) Patients who receive concomitant anti-cancer therapy, systemic immune therapy,
or hormonal therapy as cancer therapy
Patients will be excluded from study entry if any of the following criteria is met:
1) Female of child-bearing potential who is or has intention to be pregnant or
breastfeeding.
*Absence of pregnancy is to be confirmed by serum/urine human chorionic
gonadotropin (HCG) test
2) Previous radiotherapy within 3 months before study entry
3) Known brain metastasis or leptomeningeal involvement
4) Marked pleural effusion or ascites above Grade 2, based on NCI-CTCAE v4.03
criteria
5) 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
6) 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 NCICTCAE v4.03 criteria
7) Known hypersensitivity to the study drugs or the drugs with similar chemical
structures
8) 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
9) History of any other cancer other than head and neck cancer (HNC) (except
carcinoma in situ of the cervix) within the last 5 years.
10) Primary tumor of the nasopharynx (nasopharyngeal carcinoma)
11) Known HIV-1 or any active infection requiring IV antibiotics
12) Signs or symptoms of organ failure, major chronic illnesses other than cancer, or
any concomitant medical or social conditions which, based on the judgment of the
Investigator, make it undesirable for the subject to participate in the study, or
which could jeopardize compliance with the protocol
13) Patients who are unwilling or unable to comply with study procedures, or are
planning to take vacation for 7 or more consecutive days during the treatment
phase of the study
14) Use of investigational drug or device within 30 days prior to screening
15) Patients who receive prior systemic chemotherapy, except for those given for the
locally advanced disease or (neo)adjuvant therapy completed more than 3 months
prior to study drug treatment
16) Patients who receive concomitant anti-cancer therapy, systemic immune therapy,
or hormonal therapy as cancer therapy
The Estimated Number of Participants
-
Taiwan
55 participants
-
Global
55 participants
