EUCTR2005-005170-80-HU进行中（未招募）不适用
A RANDOMIZED, MULTICENTRE THERAPEUTIC CONFIRMATORY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PROXINIUM™ PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE IN PATIENTS WITH ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK WHO HAVE RECEIVED AT LEAST ONE ANTI-CANCER TREATMENT REGIMEN FOR ADVANCED DISEASE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 292
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. The patient must be 18 years of age or older.
- •2. The patient must be able to comply with scheduled study assessments and in-person visits and must have an ECOG performance status of 0, 1, 2 or 3.
- •3. The patient must have a life expectancy of at least 12 weeks.
- •4. The patient must have histologically-confirmed SCCHN.
- •5. The patient must have immunohistochemically-confirmed Ep-CAM-positive SCCHN.
- •6. The patient must have received curative intent therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy).
- •7. The patient must have documented advanced disease following treatment for their primary disease (ie, persistent or recurrent disease or second primary tumour).
- •8. The patient’s advanced disease must be refractory, meaning that the patient must have progressed on or after receiving, or was unable to tolerate, at least 1 anti-cancer treatment regimen containing 1 or more anti-cancer agents for their advanced disease, or the patient must have documented refusal of chemotherapy treatment for advanced disease.
- •9. The patient must meet the requirement of a minimum period of 2 weeks between the last dose of radiotherapy or chemotherapy or 4 weeks between the last dose of an investigational anti-cancer product, and the first dose of the study drug.
- •10. The patient must have fully recovered or reached a stable state of symptomatology from any previous treatment-related toxicity.
- •11. The patient must have at least 1 target tumour that can be designated a principal target tumour.
- •12. The patient must have adequate hepatic function [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 × upper limit of normal (ULN) and bilirubin level =1.5 × ULN].
- •13. The patient must have adequate renal function (serum creatinine < 1.5 × ULN).
- •14. The patient must have the following hematological values: granulocytes =1500/µL, platelets =75 000/µL and hemoglobin >8 g/dL.
- •15. The patient must have prothrombin time and partial thromboplastin time within normal limits.
- •16. The patient must provide written informed consent.
- •17. Women of childbearing potential (WOCBP) and male patients must be surgically incapable of bearing children or must agree to use a highly effective contraceptive method.
- •Note: The ICH guidelines define a highly effective contraceptive method as one with a failure rate of less than 1% when used consistently and correctly, such as the double barrier method.
- •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. The patient’s locoregional disease is predominantly composed of tumours that do not meet the criteria of a target tumour.
- •2. The patient has clinically significant distant metastases, including brain metastases.
- •3. The patient is a candidate for either curative surgical resection or curative intent radiotherapy, chemo-radiotherapy or chemotherapy for their advanced disease.
- •4. The patient has nasopharyngeal SCCHN.
- •5. The patient has concurrent or documented history of any 1 of the following: known Acquired Immunodeficiency Syndrome, hepatitis C or hepatitis B.
- •6. The patient has clinically significant renal or hepatic disease.
- •7. The patient has Grade 3, or higher, bleeding from any tumour.
- •8. The patient is pregnant or lactating.
- •9. The patient requires regular use of therapy that significantly alters coagulation parameters to values that exceed the ULN and are unable to safely discontinue that therapy prior to randomization.
- •10. The patient has any concomitant condition that, in the Investigator’s opinion, would make the patient inappropriate for study.
- •11. The patient is currently enrolled in a clinical trial for another investigational therapy.
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