EUCTR2012-005287-10-GB进行中（未招募）1 期
A Phase III Double-blinded, Placebo Controlled Study of Xilonix™ in Metastatic Colorectal Cancer
XBiotech Germany GmbH0 个研究点目标入组 600 人开始时间: 2016年4月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or
- •unresectable and which is refractory to standard therapy. To be considered refractory, a
- •subject must have experienced progression (or intolerance) after treatment with at least
- •all of the following agents: oxaliplatin, irinotecan, flouropyrimidine, and cetuximab or
- •panitumumab if KRAS wildtype.
- •2. Subjects will not be treated with any radiation, chemotherapy, or investigational agents
- •while enrolled in this protocol.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- •4. At least 2 weeks since the last previous cancer treatment including: chemotherapy,
- •radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics and 4
- •weeks for patients who received treatment immediately prior to the study with anti-IL-1
- •or anti-TNF agents.
- •5. Age = 18 years, male or female subjects.
- •6. Serum potassium and magnesium levels within Central Lab normal limits. Total serum
- •calcium or ionized calcium level must be greater than or equal to the lower limit of
- •normal. Subjects with low potassium, calcium and magnesium levels may be replenished
- •to allow for protocol entry.
- •7. Adequate renal function, defined by serum creatinine = 1.5 x Central Lab ULN.
- •8. Adequate hepatic function defined as:
- •total bilirubin = 1.5 times the Central upper limit ULN
- •alanine aminotransferase (ALT) = 2.0 times the Central ULN Exception: subjects with known liver metastases: = 3.0 times the Central Lab ULN for ALT.
- •9. Adequate bone marrow function as defined as:
- •absolute neutrophil count (neutrophil and bands) of = 1,500/mm3 (= 1.5 x 109/L)
- •platelet count of = 100,000/mm3 (= 100 x109/L)
- •hemoglobin of = 9 g/dL
- •10. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at
- •Screening and monthly thereafter.
- •For women who are not postmenopausal (24 months of amenorrhea) or surgically sterile
- •(absence of ovaries and/or uterus): agreement to use adequate methods of contraception,
- •during the treatment period and for at least 1 month after the last dose of study drug.
- •Acceptable contraceptive measures include:
- •- Combined (estrogen and progestogen containing) hormonal contraception associated
- •with inhibition of ovulation: Oral, Intravaginal or transdermal
- •- Progestogen-only hormonal contraception associated with inhibition of ovulation;
- •Oral, injectable or implantable, intrauterine device (IUD), intrauterine hormonereleasing
- •system(IUS)
- •- Barrier or sterilization methods such as condoms, bilateral tubal occlusion,
- •vasectomized partner or sexual abstinence
- •For men: agreement to use a barrier method of contraception during the treatment period
- •and for at least 1 month after the last dose of study drug
- •11. Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed.
- •12. Patients enrolled must, in the Investigator’s judgment, be healthy enough to stay on the
- •clinical trial for three months.
- •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 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1. Mechanical obstruction that would prevent adequate oral nutritional intake.
- •2. Serious uncontrolled medical disorder, or active infection, that would impair the ability of
- •the patient to receive protocol therapy.
- •3. Uncontrolled or significant cardiovascular disease, including:
- •A myocardial infarction within the past 6 months.
- •Uncontrolled angina within the past 3 months.
- •Congestive heart failure within the past 3 months, defined as New York Heart
- •Association (NYHA) Classes II or higher.
- •Diagnosed or suspected congenital long QT syndrome.
- •Any history of clinically significant ventricular arrhythmias (such as ventricular
- •tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome,
- •or torsade de pointes).
- •Any history of second or third degree heart block (may be eligible if currently have a pacemaker).
- •Uncontrolled hypertension (blood pressure >140 mm Hg systolic and >90 mm
- •Hg diastolic).
- •4. Dementia or altered mental status that would prohibit the understanding or rendering of
- •informed consent.
- •5. Subjects who have not recovered from the adverse effects of prior therapy at the time of enrollment to = grade 1; excluding alopecia and grade 2 neuropathy.
- •6. Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV).
- •7. Known hepatitis B surface antigen and/or positive hepatitis C antibody and presence of
- •hepatitis C RNA.
- •8. History of tuberculosis (latent or active) or known positive Interferon-gamma release assay
- •9. Receipt of a live (attenuated) vaccine within 1 month prior to Screening.
- •10. Subjects with history of hypersensitivity to compounds of similar chemical or biologic
- •composition of Xilonix™.
- •11. Women who are pregnant or breastfeeding.
- •12. WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 1 month after the last dose of study medication.
- •13. Weight loss >20% in the previous 6 months.
- •14. History of progressive multifocal leukoencephalopathy or other demyelinating disease.
- •15. Subjects on immunosuppressive therapy, including transplant patients.
研究者
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