A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or
metastatic head and neck squamous cell carcinoma
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Locations near you
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Full eligibility criteria for NCT02639858
Ages eligible for Study
20 Years to 79 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
Time of disease progression, regardless of whether that treatment or after platinum-based therapy
①Patients who have disease progression after concurrent chemoradiotherapy of curative purpose (including induction chemotherapy) including a platinum-based (cisplatin or carboplatin) chemotherapy
② Patients who have disease progression after primary or secondary treatment of palliative purpose including a platinum-based (cisplatin or carboplatin) chemotherapy
Patients who aged 20 years or older and under 79 years old
Patients whose Eastern Cooperative Oncology Group (ECOG) performance scores are 0-2
Patients who have one measurable lesion at least by RECIST criteria 1.1
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
Patients who have signed written consent forms prior to participation in the clinical trial
Patients who have Primary tumor of nasopharynx
Patients who have received treatment prior regimen of three or more drugs
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)
Previous radiotherapy is allowed, patients who should be completed radiotherapy before 4 weeks prior to the initial administration of the investigational product
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
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
Hepatic cirrhosis (≥ Child class B)
Interstitial lung disease
Mental disorder not to comply with the protocol
Uncontrolled ascites or pulmonary edema
Pregnant or lactating women
Patients considered inappropriate to participating the study by the investigator
All locations for NCT02639858
Korea, Republic of (1)
Seoul, Korea, Republic of
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View full eligibility
Tris trial is registered with FDA with number: NCT02639858. The sponsor of the trial is Samyang Biopharmaceuticals Corporation and it is looking for 31 volunteers for the current phase.
Official trial title: A Phase II Study to Evaluate the Efficacy and Safety of Docetaxel-PM in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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