EUCTR2016-000866-44-BG进行中（未招募）1 期
Phase I/II Clinical Trial of NC-6004 in Combination with 5-FU and Cetuximab as First-line Treatment in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of The Head and Neck
anoCarrier Co, Ltd0 个研究点目标入组 80 人开始时间: 2017年1月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •Each patient must meet all of the following criteria to be enrolled in this study:
- •1. Signed written informed consent prior to the initiation of any study-specific procedures.
- •2. Histologically or cytologically confirmed diagnosis of stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck not suited for local therapy.
- •Patients with stable, treated brain metastases are eligible, provided there is no evidence of progression after treatment and the patient does not require corticosteroids, or is receiving a stable dose of corticosteroids for >14 days prior to Day 1 of treatment.
- •3. Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- •4. Males or females aged 18 years at Screening.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •6. Adequate bone marrow reserve, defined as:
- •absolute neutrophil count (ANC) 1.5 × 109/L,
- •platelet count 100 × 109/L, and
- •hemoglobin (Hb) 10 g/L (transfusion is allowed to achieve Hb of 10 g/L).
- •7. Adequate liver function, defined as:
- •total serum bilirubin 2 × upper limit of normal (ULN), and
- •ALT and AST <3 × ULN or 5.0 × ULN in case of documented hepatic metastasis (ALT, AST).
- •serum albumin =3.5 g/dL
- •8. Prothrombin time within normal limits
- •9. Adequate renal function, defined as:
- •glomerular filtration rate 50 mL/min.
- •10. Have a negative pregnancy test result at Screening (for females of childbearing potential; not applicable to patients who are unable to become pregnant, including those with bilateral oophorectomy and/or hysterectomy or postmenopausal [no menses for the previous 12 months]). The test must be performed within 1 week before Day 1 of treatment.
- •11. Male patients must agree to use a condom during treatment and for 90 days after dosing. Male patients must agree not to donate sperm for 90 days after dosing.
- •12. For women of childbearing potential*: are willing to agree to use 1 of the following effective methods of birth control from the time of study entry to 6 months after the last day of treatment:
- •Combined (estrogen- and progestogen- containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
- •Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of measurable disease.
- •Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable).
- •Intrauterine devices.
- •Intrauterine hormone-releasing system.
- •Vasectomized partner who has received medical assessment of surgical success.
- •Bilateral tubal occlusion.
- •True sexual abstinence**.
- •*Patients not of childbearing potential include those who are surgically sterile or postmenopausal (no menses for the previous 12 months). For women not currently using contraceptive methods at Screening, low user-dependency contraceptive methods (eg, implantable progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner) are recommended.
- •**The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
- •13. Reasonably recovered from preceding major surgery as judged by the investigator or no major surger
排除标准
- •Patients meeting any of the following criteria will be excluded from the study:
- •1. Nasopharyngeal carcinoma.
- •2. Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 3 months before Day 1 or more than 6 months prior to Day 1 if platinum-based.
- •Prior adjuvant or neoadjuvant therapy is allowed.
- •3. Concomitant anticancer therapy, systemic immune therapy, or hormonal therapy as cancer therapy.
- •4. Unresolved toxicity from all radiation, adjuvant/neoadjuvant chemotherapy, other targeted treatment including investigational treatment (with the exception of alopecia and Grade 2 peripheral neuropathy) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
- •5. History of thrombocytopenia with complications including hemorrhage or bleeding Grade 2 NCI CTCAE v4.03 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe in the opinion of the investigator.
- •6. Known hypersensitivity to platinum compounds.
- •7. Pregnant or breastfeeding.
- •8. Active infection (infection requiring intravenous antibiotics).
- •9. Uncontrolled hypertension, defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >130 mmHg under resting conditions.
- •10. Malignancies other than head and neck cancer within 5 years prior to Day 1 of treatment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated surgically with curative intent).
- •11. Signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol.
- •12. Have pre-existing alcoholic liver injury or significant liver disease.
- •13. Have known active hepatitis B (defined as a known positive hepatitis
- •B surface antigen [HBsAg] result) or hepatitis C (defined by a known
- •positive hepatitis C antibody result and known quantitative HCV RNA
- •results greater than the lower limits of detection of the assay).
- •14. Are regularly consuming alcohol within 6 months of Screening
- •defined as an average weekly intake of >21 units (or an average daily
- •intake of >3 units) for males or >14 units (or an average daily intake >2
- •units) for females. One unit is equivalent to 8 g of alcohol: a half-pint
- •(approximately 240 mL) of beer, 1 glass (125 mL) of wine, or 1 measure
- •(25 mL) of spirits.
- •15. Have experienced any of the following within the 6-month period prior to Screening:
- •unstable angina pectoris, clinically significant coronary artery disease, cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia (patients with well-controlled cardiac arrhythmia on stable doses of medication are permitted).
- •16. Any investigational treatment within 30 days or 5 half-lives, whichever is longer, of Day 1 of treatment.
- •17. Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the treatment phase of the study without prior consent from
研究者
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