EUCTR2014-000550-12-PL进行中（未招募）1 期
A Double Blind, Placebo Controlled, Pivotal Phase III Study Evaluating Xilonix™ in Symptomatic Colorectal Cancer Patients Refractory To Standard Therapy
XBiotech Germany GmbH0 个研究点目标入组 335 人开始时间: 2014年5月12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
- 335
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
- •Subjects are included in the study if they meet all of the following
- •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 failed both an
- •oxaliplatin (oxaliplatin may have been in the adjuvant setting) and an
- •irinotecan based regimen.
- •2. Symptomatic Disease: One symptom from each domain (metabolic and functional) must be present.
- •- Evidence of metabolic dysfunction, defined as the presence of one or
- •more of the following:
- •- Any degree (up to 20%) of unintentional total body weight loss in the
- •previous 6 months
- •- Serum Interleukin 6 levels =10 pg/ml
- •- Evidence of reduced function or presence of cancer related symptoms
- •as determined by EORTC QLQ-C30.
- •- Appetite reduction, with a score of >10
- •- Presence of fatigue, with a score of >10
- •- Presence of Pain, with a score of >10
- •- Decreased Role, Emotional and Social function, with a score of < 90.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status 1 or
- •4. In the Investigator's judgment, a life expectancy of at least three (3)
- •5.In the Investigator's judgement, patients should not be expected to
- •need corticosteroids during the 8 week assessment period.
- •6. 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
- •7. For those subjects who have previously received treatment for cancer
- •related fatigue with agents such as corticosteroids or stimulants, a 2
- •week washout period is required from the last dose to C1D1.
- •8. Age =18, male or female subjects.
- •9. Serum potassium and magnesium levels within central laboratory
- •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.
- •10. Adequate renal function, defined by serum creatinine = 1.5 x ULN.
- •11. Adequate hepatic function defined as:
- •- total bilirubin = 1.5 times the central lab ULN.
- •- alanine aminotransferase (ALT) = 2.0 times the central lab ULN.
- •Exception: subjects with known liver metastases: = 3.0 times the central
- •lab ULN for ALT.
- •12. Adequate bone marrow function as defined as:
- •- absolute neutrophil count (neutrophil and bands) of ? 1,500/mm3 (?
- •1.5 x 109/L)
- •- platelet count between 150,000/mm3 and 450,000/mm3
- •- hemoglobin of = 9 g/dL
- •13. For women of childbearing potential (WOCBP), a negative serum
- •pregnancy test result at Screening.
- •14. Signed and dated institutional review board (IRB)/ Ethics Committee
- •(EC)-approved informed consent before any protocol-specific screening
- 另有 7 项未显示
排除标准
- •Subjects with ANY of the following will be excluded from the study:
- •1. Mechanical obstruction that would prevent adequate oral nutritional
- •2. >20% total body weight loss in the previous 6 months.
- •3. Serious uncontrolled medical disorder, or active infection, that would
- •impair the ability of the patient to receive protocol therapy.
- •4. 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, if defined as NYHCII.
- •- 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 >150 mm Hg systolic and
- •>95 mm Hg diastolic).
- •5. Dementia or altered mental status that would prohibit the
- •understanding or rendering of informed consent.
- •6. 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.
- •7. Subjects who have received extensive prior radiation therapy to the
- •bone marrow. Extensive radiation therapy is defined as treatment of
- •more than one axial bony metastasis. However for subjects with rectal
- •cancer pelvic irradiation, in addition to treatment of one axial bony
- •metastasis, is acceptable.
- •8. Immunocompromised subjects, including subjects known to be
- •infected with human immunodeficiency virus (HIV).
- •9. Known hepatitis B surface antigen and/or hepatitis C antibody or
- •known history of infection.
- •10. History of tuberculosis (latent or active) or positive Interferongamma
- •release assay (IGRA).
- •11. Receipt of a live (attenuated) vaccine within 1 month prior to
- •Randomization
- •12. Subjects with history of hypersensitivity to compounds of similar
- •chemical or biologic composition to Xilonix™ or any component of its
- •formulations.
- •13. Women who are pregnant or breastfeeding.
- •14. 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 randomization, for the duration of the study, and for at
- •least 3 months after the last dose of study medication.
- •15.History of progressive multifocal leukoencephalopathy or other
- •demyelinating disease.
- •16.Subjects on immunosuppressive therapy, including transplant
- •17. Subjects with known brain metastases. Subjects with symptoms of
- •brain metastases during screening should undergo CT imaging prior to
- •randomization.
研究者
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