A Randomized, Single Blind, Placebo-controlled, Multi-centre, Phase II Study of Lapatinib in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

GlaxoSmithKline Research & Development Ltd.0 个研究点目标入组 0 人开始时间: 2005年10月13日最近更新: 2019年11月25日

试验速览

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•1.Willing and able to sign a written informed consent.
•2.Histologically or cytologically confirmed diagnosis of SCCHN.
•3.Stage III, IVA and IVB disease will be eligible, who are to receive chemoradiation therapy as primary treatment (total dose = 66 Gy). Subjects with distant metastases (stage IVC) will be excluded
•4.Willing and able to have a tumour biopsy taken at screening and a second tumour biopsy taken during lapatinib/placebo administration.
•5.Male or female 18 years of age.
•6.ECOG performance status 0, 1 or 2.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Subjects with paranasal sinuses and nasal cavity tumours;
•2.Subjects who have received prior systemic chemotherapy given with curative intent;
•3.Subjects who received prior radiotherapy;
•4.Prior or concurrent treatment with tyrosine kinase inhibitors;
•5.Use of any investigational agent within 30 days or 5 half-lives, whichever is longer, preceding the first dose of lapatinib;
•6.Concurrent use of CYP3A4 inducers or inhibitors;
•7.Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
•8.Distant metastases, ie Stage IVC;
•9.Subjects taking any prohibited medication

发起方