Study comparing Tivozanib in combination with mFOLFOX6 against Bevacizumab in combination with mFOLFOX6 in patients with bowel cancer.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 252

Inclusion Criteria

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.
5.The subject has had no prior systemic chemotherapy for advanced disease; 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.If female and of childbearing potential, subject has documentation of negative pregnancy test prior to enrollment.
8.Subject (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 90 days after the last dose of study regimen.
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 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 126

Exclusion Criteria

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.- has 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.- has any of the following hematologic abnormalities:
-Hemoglobin < 9.0 g/dL
-ANC < 1500 per mm3
-Platelet count < 100,000 per mm3
-PT or PTT > 1.5 X ULN
4.-has 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.The subject has 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.The subject has 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.The subject has a non-healing wound, bone fracture, or skin ulcer.
8.The subject has inadequate recovery from any prior surgical procedure or major surgical procedure within 8 weeks prior to administration of first dose of study drug, or anticipation of major surgical procedure during the course of the study.
9.The subject has history of significant gastrointestinal (GI) toxicity, diarrhea, or stomatitis within the last 6 weeks.
10.The subject has an active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation.
11.The subject has history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug.
12.The subject has a serious/active infection or infection requiring antibiotics.
13.The subject has 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 > Grade 2
-Hemoptysis or other pulmonary bleeding > Grade 2
-Hematuria or other genitourinary bleeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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