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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02639858
• Date of registration: 14/12/2015
• Prospective Registration: No
• Primary sponsor: Samyang Biopharmaceuticals Corporation
• Public title: Study to Evaluate the Efficacy and Safety of Docetaxel Polymeric Micelle (PM) in Recurrent or Metastatic HNSCC
• Scientific title: A Phase II Study to Evaluate the Efficacy and Safety of Docetaxel-PM in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
• Date of first enrolment: October 2015
• Target sample size: 31
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02639858
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Miryung Jin

Key inclusion & exclusion criteria

Inclusion Criteria:

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

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

?Patients who have disease progression after concurrent chemoradiotherapy of curative
purpose (including induction chemotherapy) including a platinum-based (cisplatin or
carboplatin) chemotherapy

? Patients who have disease progression after primary or secondary treatment of
palliative 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: ? 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)

? 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 clinical
trial

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 cervical
cancer, skin basal cell cancer received appropriate treatment, Malignant tumor without
recurrent 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 initial
administration of the investigational product or patients who does not recover after
major 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 arrhythmia
that 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



Age minimum: 20 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Head and Neck Squamous Cell Carcinoma

Intervention(s)

Drug: Docetaxel-PM

Primary Outcome(s)

Response rate as assessed by RECIST v1.1 [Time Frame: 2 years]

Secondary Outcome(s)

Number of participants with adverse events as assessed by CTCAE v4.0 [Time Frame: 2 years]

Incidence rate of hypersensitivity reaction to Docetaxel-PM [Time Frame: 2 years]

Overall survival [Time Frame: 2 years]

Progression free survival (PFS) [Time Frame: 2 years]

Disease control rate (DCR) [Time Frame: 2 years]

Secondary ID(s)

DOCH&N201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors