PER-076-13未知未知
OPEN LABEL RANDOMIZED BIOEQUIVALENCE STUDY TO EVALUATE THEPHARMACOKINETIC (PK) AND SAFETY PROFILE OF BEVACIZUMABBIOSIMILAR (BEVZ92) IN COMBINATION WITH FOLFOX ORFOLFIRI VERSUS BEVACIZUMAB (AVASTIN®) IN COMBINATIONWITH FOLFOX OR FOLFIRI AS FIRST-LINE TREATMENT IN PATIENTSWITH METASTATIC COLORECTAL CANCER (MCRC)
mAbxience S.A.,0 个研究点目标入组 0 人开始时间: 2014年11月28日最近更新:
试验速览
- 阶段
- 未知
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 100（—）
入选标准
- •Patients eligible for inclusion in this study must fulfil all the following
- •criteria: 1. Patients must have signed an informed consent before any study related procedure or evaluation is performed. 2. Patients must be _ 18 years of age. 3. Patient must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy. 4. Patient with mCRC for whom bio-chemotherapy is indicated.
- •5. Patients must have at least one measurable non-irradiated site of disease according to RECIST (version 1.1) criteria. If the patient has had previous irradiation of the marker lesion(s), there must be evidence of progression since the radiation. Measurable disease: must be accurately measured in at least
- •one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of:
- •10mm by CT scan (irrespective of scanner type) and MRI (no less than double the slice thickness and a
- •minimum of 10mm) 10mm caliper measurement by clinical exam (when superficial), 20mm by chest X-ray (if clearly defined and surrounded by aerated lung). 6. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy(adequately recovered from the acute toxicities of any prior therapy) 7. ECOG performance status _ 2.
- •8. Adequate bone marrow function defined as:
- •Absolute Neutrophil count (ANC) _ 1.5x109/L Platelets _ 100 x109/L Hb _10g/dL.
- •9. Adequate liver function defined as: Total bilirrubin _ 1.5x upper limit of normal (ULN) AST/ALT _ 2.5x ULN in patient without liver metastasic or _5 x ULN in patient with liver metastasis10. Adequate renal function defined as: Serum creatinine _ 1.5x ULN or Creatinine clearance _
- •50 ml/minute as calculated by the Cockroft-Gault method. Urine dipstick for proteinuria < 2+. If urine dipstick is _2+, 24 hour urine must demonstrate _ 1g protein in 24 hours or must have a urine protein-to creatinine ratio (UPCR) < 1.0 mg 11. Adequate coagulation parameters such as: International ormalized ratio (INR) _ 1.5 and activated prothrombin time (aPTT) _ 1.5 x ULN within 7 days prior to randomization for patients not receiving anticoagulation therapy. The use of full-dose oral or parenteral anticoagulants is
- •permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard of
- •the enrolling institution) and the patient has been on a stabledose of anticoagulants for at least two weeks prior to the first study treatment. (Patients on warfarin have to have switched to lowmolecular-
- •weight heparin for >1 week at time of treatment start). 12. Negative pregnancy test for females of a childbearing potential. 13. Use of an effective form of contraception during the study (for
- •subjects of childbearing potential and their partners).14. Life expectation _ 3 months
排除标准
- •Patients eligible for inclusion in this study must not have any of following exclusion criteria:
- •1. Prior treatment for advanced or metastatic colorectal cancer. 2. Prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting. 3. Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment). 4. History of any other malignancy unless the malignancy is in complete remission and the patient has been off all therapy for that
- •malignancy for at least 5 years. 5. Chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed. 6. Scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry. Uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal
- •metastases. 8. Patients with active bleeding or history of bleeding diathesis on oral anti-vitamin K medication (except low dose coumadin) within the past 6 month prior to randomization or coagulopathy.
- •9. Patients with history of cerebral vascular accident, transient ischemic attack, or subarachnoid haemorrhage within the past 6 month prior to randomization. 10. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation
- •in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction _ 6 months prior to first study treatment and deep venous thrombosis, serious
- •uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease or uncontrolled hypertension; significant vascular disease (e.g. aortic aneurysm surgical repair or recent peripheral arterial thrombosis) _ 6 months prior to randomization; uncontrolled diabetes defined by fasting serum glucose >1.5x ULN; any active (acute or chronic) or uncontrolled infection/disorders requiring antibiotics on first drug administration non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by any of the study treatments; known liver disease such as cirrhosis, chronic active
- •hepatitis or chronic persistent hepatitis; uncontrolled seizures; a known history of HIV seropositivity.
- •11. Patients with serious non-healing wound, ulcer, bone fracture, or with a major surgical procedure, or significant traumatic injury within 4 weeks prior to randomization 12. Patients with clinical symptoms or signs of gastrointestinal obstruction that require parenteral hydration and/or nutrition. 13. Patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization. 14. Patients with history of hypersensitivity to any of the study drugs
- •or ingredients.
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