EUCTR2005-004939-22-GR进行中（未招募）不适用
A PHASE I/II EFFICACY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH RECURRENT OR METASTATIC NON-NASOPHARYNGEAL HEAD AND NECK CANCER
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.histological confirmation of evidence of squamous cell carcinoma of the head and neck diagnosed by biopsy
- •2.patients must have available tumour tissue for translational research studies
- •3.Patients could have received any treatment for locoregional disease including surgery, radiotherapy, chemotherapy or any possible combination
- •4.Patients must be able to ingest capsules per os.
- •5.female or male patients aged 18 years and over
- •6.life expectancy ³8 weeks
- •7.ECOG Performance Status 0, 1 or 2 (see Appendix I)
- •8.provision of informed consent
- •9.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •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
排除标准
- •1.carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumours
- •2.isolated recurrent disease that may be amenable to local therapy eg, surgical intervention or radiation therapy
- •3.Patients fed through a naso-gastric or a gastric tube.
- •4.Any prior systemic treatment for recurrent or metastatic disease
- •5.Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
- •6.Diagnosis of any second malignancy, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
- •7.History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan.
- •8.Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- •9.Ongoing cardiac dysrhythmias of grade ³2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.
- •10.Hypertension that cannot be controlled by medications (>150/100 mm/Hg despite optimal medical therapy).
- •11.Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- •12.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •13.Concurrent treatment with other experimental drugs and/or anticancer agents
- •14.Pregnancy or breastfeeding. Patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- •15.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial
- •16.any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- •17.any third space accumulation of fluid (oedema, effusion, ascites)
研究者
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