To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Intervention: SCB01A
Intervention description: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: SCB01A; squamous cell carcinoma of head and neck

Summary:

      The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of
      SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous
      platinum based therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged ≥20 years;

          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:

               1. Absolute neutrophil count (ANC) > 1.5 x 109/L;

               2. White blood cell (WBC) > 3 x 109/L;

               3. Platelet count > 75 x 109/L;

               4. Hemoglobin > 9 g/dL ( > 5.6 mmol/l);

               5. Prothrombin time (PT)/international normalized ratio (INR) ≤1.5 x upper limit of
                  normal (ULN);

               6. Creatinine clearance (Cockcroft & Gault formula) >50 mL/min;

               7. Alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT)
                  and Alkaline Phosphatase (ALP) < 3 x ULN; AST/ALT≦5 x ULN if liver metastasis;

               8. Serum albumin ≥ 3 g/dL;

               9. Total Bilirubin ≤ 1.5 x ULN;

              10. QTc <450 msec

        Exclusion Criteria:

          1. Known primary CNS malignancy or CNS involvement (except for brain metastases that have
             been treated and are stable and subject is off steroids);

          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.