EUCTR2013-005108-32-GB进行中（未招募）1 期
A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TOEVALUATE THE EFFICACY AND SAFETY OF RO5520985 (VANUCIZUMAB)PLUS FOLFOX VERSUS BEVACIZUMAB PLUS FOLFOX IN PATIENTS WITHPREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 190
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 or cytologically confirmed mCRC not amenable to
- •potentially curative resection with at least one measurable metastatic
- •lesion, as defined by RECIST v1.1
- •a)Results of local RAS mutational analysis must be available for
- •stratified randomization
- •b)Representative tumor specimens in FFPE blocks (preferred) or slides
- •must be available for central extended RAS mutational analysis testing
- •2.Signed written informed consent, obtained prior to any screening
- •3.Age> 18 years
- •4.ECOG (WHO) performance status of 0 or 1
- •5.Adequate hematologic, liver, renal, coagulation and cardiovascular
- •6.Recovery from all reversible adverse events of previous medical
- •therapies to baseline or NCI CTCAE Grade 1, except for alopecia (any
- •7.Negative serum pregnancy test within 7 days prior to starting study
- •treatment in premenopausal women and women < 2 years after the
- •onset of menopause
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, immunotherapy, hormonal therapy) before Day 1 of Cycle 1 for treatment of mCRC
- •Patients who received prior systemic adjuvant therapy or radiotherapy for CRC are not excluded if the time interval from last administration of adjuvant therapy until disease progression is > 12 months
- •2.Radiotherapy within 28 days and abdominal/ pelvic radiotherapy
- •within 60 days prior to Day 1 of Cycle 1, except palliative radiotherapy to bone lesions within 7 days prior to Day 1 of Cycle 1
- •3.Symptomatic CNS metastases or carcinomatous meningitis:
- •4.Significant cardiovascular or cerebrovascular disease within 6 months prior to Day 1 of Cycle 1
- •5.Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- •6.Current use of anticoagulants (e.g., warfarin or any other coumadin-derivate coagulants) at therapeutic doses within 7 days prior to study drug administration. Prophylactic use of unfractioned heparin or low molecular weight heparin (LMWH) is permitted (e.g., enoxaparin 40 mg QD)
- •7.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study or nonrecovery from side effects of any such procedure
- •8.History of abdominal or tracheo-oesophageal fistula or GI perforation or intra abdominal abscess within 6 months prior to Day 1
- •9.Clinical signs or symptoms of GI obstruction or a requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
- •10.Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- •11.History of bronchopulmonary hemorrhage NCI CTCAE > Grade 2 within 2 months prior to randomization
- •12.Severe, nonhealing or dehiscing wound, active ulcer, or untreated bone fracture
- •13.Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5 FU toxicity
- •14.History of intra-abdominal inflammatory process within 6 months
- •prior to Day 1 of Cycle 1, including but not limited to peptic ulcer
- •disease, diverticulitis,or colitis.
- •15. Colonic prosthesis (stent) implant in place.
研究者
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