NCT02639858Unknown2 期
A Phase II Study to Evaluate the Efficacy and Safety of Docetaxel-PM in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Response rate as assessed by RECIST v1.1
研究概览
简要总结
A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or metastatic head and neck squamous cell carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •Patients who have signed written consent forms prior to participation in the clinical trial
排除标准
- •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
- •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
- •Pregnant or lactating women
- •Patients considered inappropriate to participating the study by the investigator
研究组 & 干预措施
Docetaxel-PM
Experimental
Docetaxel-PM 75mg/m2 IV infusion
干预措施: Docetaxel-PM (Drug)
结局指标
主要结局
Response rate as assessed by RECIST v1.1
时间窗: 2 years
Response is confirmed at least 4 weeks later. Assessment: every 6 weeks (treatment period), every 2 months (follow-up period)
次要结局
- Overall survival(2 years)
- Number of participants with adverse events as assessed by CTCAE v4.0(2 years)
- Progression free survival (PFS)(2 years)
- Disease control rate (DCR)(2 years)
- Incidence rate of hypersensitivity reaction to Docetaxel-PM(2 years)
研究者
研究点 (1)
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