Clinical Trials List
2017-06-08 - 2019-04-30
Phase II
Terminated4
ICD-10C44.42
Squamous cell carcinoma of skin of scalp and neck
An Open-Label, Phase II Study to Evaluate the Efficacy and Safety of SCB01A in Subjects with Recurrent or Metastatic Squamous Cell Head and Neck Cancer Who Have Failed Platinum-Based Treatment
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Trial Applicant
A2 HEALTHCARE TAIWAN CORPORATION
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Sponsor
SynCore Biotechnology Co., Ltd
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Sheng-Yu Chen Division of Hematology & Oncology
- 陳盛裕 Division of Hematology & Oncology
- Muh-Hwa Yang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
6 Stop recruiting
Audit
None
Co-Principal Investigator
- 吳沅樺 Division of Radiation Therapy
- Shang-Yin Wu Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- 蘇勇誠 Division of Hematology & Oncology
- Yao-Yu Hsieh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Yu-Min Liao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Objective response rate (ORR), defined as complete response (CR) + partial response (PR),
according to RECIST v1.1 criteria
Secondary endpoints:
Progression free survival (PFS)
Overall survival (OS) after first treatment with SCB01A
Best overall tumor response after treatment with SCB01A
Safety: The safety endpoints used to achieve the secondary objectives of this study are:
o Hematology, clinical chemistry, coagulation factors and urinalysis laboratory data
changes
o AE/SAE incidence
o Physical examination result changes
o Vital sign changes
o Electrocardiogram (ECG) (including PR, QRS, QTc intervals) results
Inclution Criteria
2. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment;
3. Histological or cytological confirmed squamous cell carcinoma of head and neck, excluding nasopharyngeal carcinoma;
4. Subjects with unresectable, unfeasible radiotherapy, recurrent or metastatic head and neck squamous cell carcinoma, after previous treatment with platinum agent;
5. Subjects must have at least one measurable tumor lesion as defined by RECIST version 1.1 as assessed by the investigator (local radiological image assessment) or clinically evaluable disease. Physical and neurological examinations, and radiographic studies have to be performed within 28 days of Cycle 1 Day 1;
6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1;
7. Life expectancy of 12 weeks or longer;
8. Concurrent local therapy is not allowed, but concurrent palliative radiation therapy to non-measurable sites of disease such as painful bone metastasis is permitted;
9. All eligible subjects of childbearing potential have to use effective contraception; that is, double barrier contraceptive methods;
10. Documented progressive disease within past 6 months;
11. Adequate bone marrow reserve, cardiac, renal and liver function:
a) Absolute neutrophil count (ANC) > 1.5 x 10^9/L;
b) White blood cell (WBC) > 3 x 10^9/L;
c) Platelet count > 75 x 10^9/L;
d) Hemoglobin > 9 g/dL ( > 5.6 mmol/l);
e) Prothrombin time (PT)/international normalized ratio (INR) ≤1.5 x upper limit of normal (ULN);
f) Creatinine clearance (Cockcroft & Gault formula) >50 mL/min;
g) Alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT) and Alkaline Phosphatase (ALP) < 3 x ULN; AST/ALT≦5 x ULN if liver metastasis;
h) Serum albumin ≥ 3 g/dL;
i) Total Bilirubin ≤ 1.5 x ULN;
j) QTc <450 msec
Exclusion Criteria
2. Chemotherapy, radiation therapy, major surgery or investigational agents including immune or target therapies less than 4 weeks prior to study drug treatment;
3. History of malignancy other than head and neck cancer with the exception of early stage non-melanoma skin cancer or carcinoma in situ of cervix;
4. History of liver cirrhosis;
5. Active hepatitis B or hepatitis C infection;
6. Clinical significant pulmonary obstructive or clinical significant pulmonary restrictive diseases (grade >2);
7. Clinically significant cardiac disease (NYHA class > 2);
8. Other serious illness or medial conditions, such as active infection, unresolved bowel obstruction, or psychiatric disorders;
9. Known HIV positivity;
10. Pregnant or breast-feeding subjects, and men and women of child-bearing potential not using effective contraception while on study treatment;
11. Known hypersensitivity to any component of SCB01A or excipients including Solutol®, alcohol, and PEG300;
12. History of exposure to SCB01A or its analogues;
13. History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere with the clinical and radiological evaluation of central nervous system during the trial;
14. Peripheral neuropathy (≥ grade 2);
15. Any other reason the investigator deems the subject to be unsuitable for the study.
The Estimated Number of Participants
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Taiwan
37 participants
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Global
0 participants
