EUCTR2011-000902-24-BE进行中（未招募）1 期
An open-label, single arm, phase II trial to investigate the safety and efficacy of Sym004 in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have failed anti-EGFR monoclonal antibody-based therapy - Not available
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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. Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
- •2. Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation
- •3. Previous treatment with a marketed anti-EGFR mAb in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
- •a. Documented clinical benefit or response for at least 8 weeks (PR, CR or SD verified by CT scan or MRI according to RECIST) on the anti-EGFR mAb-based therapy and
- •b. Documented disease progression (PD verified by CT scan or MRI according to RECIST) during or within 12 weeks following the last administration of anti-EGFR mAb
- •4. Accessible tumor for biopsy and patient acceptance of repeat tumor biopsies
- •5. At least one measurable lesion according to RECIST (1.1) at screening*
- •6. ECOG performance status 0-1
- •7. Normal organ or bone marrow function as defined below:
- •a. ANC > 1.5 x109/L (1,500/mm3)
- •b. Hemoglobin = 9 g/dl
- •c. Platelet count = 75 x109/L (75,000/mm3)
- •d. Bilirubin < 1.5 x upper normal limit
- •e. Alkaline Phospatase = 2.5 x upper normal limit (unless known bone metastases)
- •f. AST(SGOT)/ALT(SGPT) = 2.5 x upper normal limit (unless known liver metastases)
- •g. Serum creatinine =1.5 x upper normal limit or creatinine clearance > 50 ml/min calculated according to Cockroft-Gault
- •h. S-Na, S-K, S-Mg and S-Ca CTCAE < grade 3 for both low and high values
- •8. Age =18 years
- •9. Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out
- •* Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. More than 2 lines of prior chemotherapy in the palliative setting
- •2. Expected survival <12 weeks
- •3. Patients with known brain metastases
- •4. Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
- •5. Anti-EGFR mAbs within 14 days prior to Visit 2
- •6. Patients with known previous grade > 3 infusion related reactions with chimeric monoclonal antibodies
- •7. History of other malignancy within 5 years prior to Visit 2, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix or urinary bladder
- •8. Severe infection requiring iv treatment
- •9. Any other concurrent uncontrolled disease or medical conditions that are deemed to interfere with the conduct of the trial as judged by the investigator
- •10. Major surgery within 4 weeks prior to Visit 2 and patients must have recovered from effects of major surgery
- •11. Known HIV positive
- •12. Known active hepatitis B or C
- •13. Patients with known allergy to the components in the study drug
- •14. Clinically significant and uncontrolled cardiac disease including unstable angina, acute myocardial infarction within six months prior to Visit 2, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities and controlled and well treated chronic atrial fibrillation
- •15. Current participation in any other interventional clinical trial
- •16. Patients known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- •17. Male patients not willing to use adequate contraception or female of childbearing potential not willing to use an effective form of contraception such as hormonal birth control, intrauterine device or double barrier method during treatment with Sym004 and at least 3 months thereafter
- •18. Breast feeding women or women with a positive pregnancy test at Visit 1
研究者
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