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临床试验/PER-053-06
PER-053-06已完成未知

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER AND PHASE II STUDY ON LAPATINIB ADMINISTERED BY THE ORAL ROUTE IN COMBINATION WITH RADIOTHERAPY AND CISPLATINE CONCURRENTS AGAINST RADIOTHERAPY AND CISPLATINE AS UNIQUE AGENTS, IN PATIENTS WITH CARCINOMA OF HEAD CELLS AND NECK WITH STAYS III AND IVA, B (SCCHN, SQUAMOUS CELL CARCINOMA OH THE HEAD AND NECK)

GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 4 人开始时间: 2006年8月24日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
4
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
0 至 0（—）

入选标准

  • •1. Decision and ability to sign a written informed consent.
  • •2. Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck.
  • •3. Prior to enrollment, patients should have overexpression of ErbB1 receptors.
  • •4. Patients with disease in stage III and in IVA / IVB stages who must receive chemotherapy with cisplatin and radiation therapy as the primary treatment.
  • •5. Decision and ability to be subjected to a tumor biopsy in the selection.
  • •6. Male or female ≥ 18 years of age.
  • •7. Criteria for female patients or female partners of male patients: A) Without potential to have a family. B) With potential to have family: These patients must have a negative result in the serum test to diagnose pregnancy in the screening and must agree to comply with the following: • Complete abstinence from sexual intercourse from 2 weeks before administering the first dose of the medication under study up to 28 days after the final dose of the study medication; or • Consistent and correct use of acceptable methods for the control of
  • •8. Score of 0, 1, or 2 for the performance condition according to the Cooperative Group in Eastern Oncology (ECOG).
  • •9. Patients should have an adequate hematologic, renal and hepatic function.
  • •10. Fraction of left ventricular ejection within the normal institutional ranges, determined with echocardiogram or with the multiple entry acquisition study (MUGA).
  • •11. In ability to swallow tablets whole or swallow a suspension of tablets dissolved in water at the time of inclusion in the study.
  • •12. The life expectancy must be at least 6 months.

排除标准

  • •1. Nasopharyngeal tumors, in the paranasal sinuses or in the nasal cavity.
  • •2. Any previous or current treatment for an invasive head and neck cancer of any kind.
  • •3. Concurrent use of inducers or inhibitors of the CYP3A4 system.
  • •4. Patients with a known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
  • •5. History of another malignancy during the last 5 years.
  • •6. Peripheral neuropathy of one degree ≥2.
  • •7. Pregnant women or women who are breastfeeding.
  • •8. Malabsorption syndrome, a disease that significantly affects gastrointestinal function, which could compromise the absorption of lapatinib.

研究者

发起方
GLAXOSMITHKLINE PERU S.A.,

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