A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or metastatic head and neck squamous cell carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Docetaxel PM 75mg/m2 IV infusion
Samyang Biopharmaceuticals
Seoul, South Korea
RECRUITINGResponse rate as assessed by RECIST v1.1
Response is confirmed at least 4 weeks later. Assessment: every 6 weeks (treatment period), every 2 months (follow-up period)
Time frame: 2 years
Progression free survival (PFS)
Assessment: every 2 months (follow-up period)
Time frame: 2 years
Disease control rate (DCR)
DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease
Time frame: 2 years
Overall survival
Assessment: every 2 months (follow-up period)
Time frame: 2 years
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
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