Study to Evaluate the Efficacy and Safety of Docetaxel Polymeric Micelle (PM) in Recurrent or Metastatic HNSCC

Inclusion Criteria:

1. Patients who were histologically or cytologically diagnosed as having oral cavity,oropharynx, hypopharynx, or larynx squamous cell carcinoma with recurrent andmetastatic evidence and who cannot be treated by salvage surgery or radiotherapy

2. Time of disease progression, regardless of whether that treatment or afterplatinum-based therapy

①Patients who have disease progression after concurrent chemoradiotherapy of curativepurpose (including induction chemotherapy) including a platinum-based (cisplatin orcarboplatin) chemotherapy

② Patients who have disease progression after primary or secondary treatment ofpalliative purpose including a platinum-based (cisplatin or carboplatin) chemotherapy

3. Patients who aged 20 years or older and under 79 years old

4. Patients whose Eastern Cooperative Oncology Group (ECOG) performance scores are 0-2

5. Patients who have one measurable lesion at least by RECIST criteria 1.1

6. Patients who show adequate function of organ:

• bone marrow: Absolute Neutrophil count (ANC) ≥ 1,500/μL, Platelet count ≥ 100,000/μ, Hb≥ 9.0 g/dl (allowed blood transfusion)

• Liver: ① with no evidence of liver metastasis; Total bilirubin ≤ 1.5mg/dl,alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT) ≤ 2.0 X upper limit of normal (ULN)

② with liver metastasis; bilirubin ≤ 3.0 X ULN, aspartate transaminase (AST),alanine transaminase (ALT) ≤ 5.0 X ULN

• Kidney: creatinine ≤ 1.5 X ULN

7. Patients who have signed written consent forms prior to participation in the clinicaltrial

Exclusion Criteria:

1. Patients who have Primary tumor of nasopharynx

2. Patients who have received treatment prior regimen of three or more drugs

3. Patients who have Primary malignant tumors of other sites (except if; early cervicalcancer, skin basal cell cancer received appropriate treatment, Malignant tumor withoutrecurrent state treated five years previously)

4. Previous radiotherapy is allowed, patients who should be completed radiotherapy before 4 weeks prior to the initial administration of the investigational product

5. Patients who have received a major surgery within 4 weeks prior to the initialadministration of the investigational product or patients who does not recover aftermajor surgery

6. Patients who have severe diseases or medical condition as follows

• Congestive heart failure(NYHA class III or IV)

• Unstable angina, cardiac infarction within 6 months

• Second-degree atrioventricular (AV) block or more, clinically cardiac arrhythmiathat needs drug therapy

• Uncontrollable Hypertension

• Hepatic cirrhosis (≥ Child class B)

• Interstitial lung disease

• Mental disorder not to comply with the protocol

• Uncontrolled diabetes

• Uncontrolled ascites or pulmonary edema

• Active infection

7. Pregnant or lactating women

8. Patients considered inappropriate to participating the study by the investigator