EUCTR2009-014440-10-NL进行中（未招募）不适用
A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination with Cetuximab in Second-Line Cetuximab-Naïve Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) - EMD 1201081 in Cetuximab-Naïve Subjects with R/M SCCH
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 104
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. Signed and dated written informed consent prior to any trial-specific procedure.
- •2. Male or female, age = 18 years.
- •3. Histologically confirmed squamous cell carcinoma of the head and neck that is recurrent and/or metastatic; documented in the medical record.
- •4. History of progressing disease on a first-line cytotoxic chemotherapy regimen such as 5-FU + cisplatin, taxanes, etc. for their R/M SCCHN. (A history of chemotherapy/ radiation therapy for localized disease does not count as a first-line regimen.)
- •5. The subject is suited for systemic therapy in the opinion of the Investigator.
- •6. At least one radiographically documented lesion assessable according to RECIST 1.0. Lesions in previously irradiated areas should be measurable (i.e. the lesion must be adequately measurable in at least one dimension; longest diameter to be recorded as = 2 cm by conventional techniques or = 1 cm by spiral CT scan). If the sole site of measurable disease is in a prior radiation field, there must be unequivocal evidence of progression at = 8 weeks since the completion of radiation or a positive biopsy.
- •7. ECOG performance status of 0 or 1.
- •8. If female, either post-menopausal, surgically sterile, or having a negative urine or serum pregnancy test (ß-HCG) at screening and practicing medically accepted contraception. If male, practicing contraception if risk of conception exists. For relevant subjects, the duration of contraception should be 1 week prior to the start of therapy through 4 weeks after receipt of trial therapy.
- •9. Recovered from previous toxicities of prior cytotoxic regimen to CTCAE Grade 1 (with the exception of alopecia).
- •10. Hemoglobin = 9 g/dL (without transfusion support, no transfusion within 7 days of screening).
- •11. Neutrophils = 1.5 x 109/L.
- •12. Platelets = 100 x 109/L.
- •13. PT/PTT = 1.5 times the upper limit of normal for the site, unless there is therapeutic anti-coagulation (see below; INR values should be converted to PT for screening).
- •14. Serum creatinine = 1.5 times the upper limit of normal for the site.
- •15. ALT and AST = 3 times the upper limit of normal for the site.
- •16. Be willing and able to comply with the protocol procedures for the duration of the trial.
- •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. History of prior exposure to cetuximab or panitumumab or any other approved or investigational anti-EGFR agents.
- •2. Undifferentiated nasopharyngeal carcinoma.
- •3. Chemotherapy, radiotherapy or any investigational agents within 4 weeks of first dose of trial medication.
- •4. Major surgical or planned procedure within 30 days prior to first dose of trial medication (isolated biopsies are not counted as major surgical procedures).
- •5. Other active malignancy besides non-metastatic basal cell or squamous cell carcinoma of the skin or second primary squamous cell carcinoma
- •of the head and neck.
- •6. Impaired cardiac function (e.g. left ventricular ejection fraction < 45% defined by
- •echocardiograph or other study), history of uncontrolled serious arrhythmia, unstable
- •angina pectoris, congestive heart failure NYHA III and IV), myocardial infarction within
- •the last 12 months prior to trial entry, signs of pericardial effusion.
- •7. Hypertension uncontrolled by standard pharmacologic therapies.
- •8. History of diagnosed interstitial lung disease.
- •9. Patient requires systemic anti-coagulation (e.g. warfarin > 10 mg/day).
- •10. Pregnancy or breast feeding.
- •11. Legal incapacity or limited legal capacity.
- •12. Significant medical or psychiatric disease which makes the trial inappropriate for the subject in the Investigator’s opinion.
- •13. Any brain metastasis and/or leptomeningeal disease (known or suspected).
- •14. Significant pre-existing immune deficiency such as infection by HIV (documented or known).
- •15. Clinically significant ongoing infection.
- •16. Known hypersensitivity to the trial treatments.
- •17. Participation in another clinical trial within the past 30 days.
- •18. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
- •19. Other significant disease that in the Investigator’s opinion would exclude the subject from the trial.
研究者
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