EUCTR2011-003502-24-AT进行中（未招募）不适用
A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination with mFOLFOX6 with Bevacizumab in Combination with mFOLFOX6 in Stage IV Metastatic Corectal Cancer (mCRC) Subjects - Not available
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 252
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
- •Subject is eligible for the study if all of the following apply:
- •1.) The subject, prior to any study-related procedures, has provided
- •IRB/IEC approved written Informed Consent and privacy language as
- •per national regulations (e.g., HIPAA Authorization for US sites).
- •2.) The subject is male or female, aged 18 years or older.
- •3.) The subject has histologically or cytologically confirmed mCRC for
- •which bevacizumab/ mFOLFOX6 chemotherapy regimen would be the
- •appropriate treatment per the investigator.
- •4.) The subject has at least one measurable lesion by RECIST Version
- •1.1. A lesion that has received prior radiotherapy may only be counted as
- •a target lesion if it has progressed since radiotherapy as determined by
- •PI or radiologist assessment.
- •5.) The subject has had no prior systemic chemotherapy for advanced
- •colorectal cancer; no fluorouracil containing adjuvant therapy in
- •previous 6 months.
- •6.) The subject has an Eastern Cooperative Oncology Group (ECOG)
- •performance status of 0 or 1.
- •7.) Female subject must be either:
- •post-menopausal (defined as women who are > 46 years of age and
- •last menstrual period was more than 2 years ago) prior to Screening, or
- •premanarchal prior to Screening, or
- •documented surgically sterile or status post hysterectomy (at least 1
- •month prior to
- •Screening), or
- •if of childbearing potential, must have a negative serum or urine
- •pregnancy test at Screening. All females of childbearing potential who
- •are sexually active will be required to use highly effective contraception
- •consisting of two forms of birth control (one of which must be a barrier
- •method) starting at Screening and throughout the study period and for
- •90 days after final study drug administration. Highly effective
- •contraception is defined as established use of oral, injected or implanted
- •hormonal methods of contraception, placement of an intrauterine device
- •(IUD) or intrauterine system (IUS), or barrier methods of contraception
- •including a condom or occlusive cap (diaphragm or cervical/vault caps)
- •with spermicidal foam/gel/film/cream/suppository.
- •8.) Male subject and their female spouses/partners who are of
- •childbearing potential and sexually active must be using highly effective
- •contraception consisting of two forms of birth control (one of which
- •must be a barrier method) starting at Screening and continue
- •throughout the study period and for 90 days after final study drug
- •administration. Highly effective contraception is defined as established
- •use of oral, injected or implanted hormonal methods of contraception,
- •placement of an intrauterine device (IUD) or intrauterine system (IUS),
- •or barrier methods of contraception including a condom or occlusive cap
- •(diaphragm or cervical/vault caps) with spermicidal
- •foam/gel/film/cream/suppository.
- •9.) Female subject must not be breastfeeding at Screening or during the
- •study period and for 90 days after final study drug administration.
- •10.) Female subject must not donate ova starting at Screening and
- •throughout the study period and for 90 days after final study drug
- 另有 10 项未显示
排除标准
- •The subject has;
- •1. had any prior VEGF-directed therapy including VEGF antibody or any other agent or investigational agent targeting the VEGF pathway.
- •2. primary CNS malignancies or CNS metastases; subjects with previously treated brain metastases will be allowed if the brain metastasis have been stable without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
- •3. any of the following hematologic abnormalities:
- •Hemoglobin < 9.0 g/dL (90 g/L, 5.5854 mmol/L)
- •ANC < 2000 per mm3
- •Platelet count < 100,000 per mm3
- •PT or PTT > 1.5 X ULN
- •4. any of the following serum chemistry abnormalities:
- •Total bilirubin > 1.5 X ULN (or > 2.5 X ULN for subjects with Gilbert's syndrome)
- •AST or ALT > 2.5 X ULN (or > 5 X ULN for subjects with liver metastasis)
- •Alkaline phosphatase > 2.5 X ULN (or > 5 X ULN for subjects with liver or bone metastasis)
- •Serum albumin < 2.0 g/dL
- •Creatinine > 1.5 X ULN (or calculated creatinine clearance <
- •60mL/min/1.73m2)
- •Proteinuria > 2+ by urine dipstick; protein greater than 2+ must have
- •24-hour urine collection that is less than 2 gm/24hr
- •5. significant cardiovascular disease, including:
- •History of clinically symptomatic left ventricular failure
- •Uncontrolled hypertension: Systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 24 hours apart
- •Hypertensive crisis or hypertensive encephalopathy within 6 months
- •prior to administration of first dose of study drug
- •Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug
- •History of serious ventricular arrhythmia
- •Cardiac arrhythmias requiring anti-arrhythmic medications (except for
- •atrial fibrillation that is well-controlled with anti-arrhythmic medication)
- •Significant structural or congenital heart disease
- •6. significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug, including but not limited to:
- •Deep vein thrombosis
- •Pulmonary embolism
- •Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •Peripheral arterial ischemia > Grade 2
- •Coronary or peripheral artery bypass graft
- •7. a non-healing wound, bone fracture, or skin ulcer.
- •8. inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug, or anticipation of major surgical procedure during the course of the study.
- •9. history of significant gastrointestinal (GI) toxicity, diarrhea, or
- •stomatitis within the last 6 weeks.
- •10. active peptic ulcer disease, inflammatory bowel disease, ulcerative
- •colitis, or other gastrointestinal condition with increased risk of perforation.
- •11. history of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 4 weeks prior to administration of first dose of study drug.
- •12. a serious/active infection or infection requiring antibiotics.
- •13. significant bleeding disorders within 6 months prior to administration of first dose of study drug, including but not limited to:
- •Hematemesis, hematochezia, melena or other gastrointestinal bleeding not directly attributable to mCRC > Grade 2. For subjects with
- •gastrointestinal bleeds attributable to their underlying mCRC, this should be = Grade 3 at the time of study entry.
研究者
相似试验
进行中（未招募）
不适用
Study comparing Tivozanib in combination with mFOLFOX6 againstBevacizumab in combination with mFOLFOX6 in patients with bowelcancer.EUCTR2011-003502-24-ITASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.252
进行中（未招募）
不适用
Study comparing Tivozanib in combination with mFOLFOX6 against Bevacizumab in combination with mFOLFOX6 in patients with bowel cancer.Metastatic colorectal cancer (CRC)MedDRA version: 16.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003502-24-HUAstellas Pharma Global Development, Inc.252
进行中（未招募）
不适用
Study comparing Tivozanib in combination with mFOLFOX6 against Bevacizumab in combination with mFOLFOX6 in patients with bowel cancer.Metastatic colorectal cancer (CRC)MedDRA version: 14.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003502-24-BEAstellas Pharma Global Development, Inc.252
进行中（未招募）
不适用
Study comparing Tivozanib in combination with mFOLFOX6 against Bevacizumab in combination with mFOLFOX6 in patients with bowel cancer.EUCTR2011-003502-24-ESAstellas Pharma Global Development, Inc.252
进行中（未招募）
不适用
Study comparing Tivozanib in combination with mFOLFOX6 against Bevacizumab in combination with mFOLFOX6 in patients with bowel cancer.Metastatic colorectal cancer (CRC)MedDRA version: 16.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003502-24-FIAstellas Pharma Global Development, Inc.252