A Biomarker Study of Tivozanib in Subjects With Advanced Renal Cell Carcinoma

Completed · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

This is an open-label, single arm, multicenter study. Subjects will be stratified by histology (clear cell versus non-clear cell). Enrollment of non-clear cell subjects will be limited to ≤ 30% of the entire study population.

Key facts

Study ID

NCT01297244

Run by

AVEO Pharmaceuticals, Inc.

People needed

105

Starts

2011-01-01

Expected to finish

2012-10-01

Last updated by the study team

2020-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 year old males or females
• Subjects with unresectable locally recurrent or metastatic renal cell carcinoma (RCC)
• Histologically or cytologically confirmed clear cell renal cell carcinoma (≥ 50% clear cell) or non-clear cell RCC (all histologies)
• Subjects must have undergone prior nephrectomy (complete or partial) for excision of the primary tumor.
• Measurable disease per RECIST criteria Version 1.1 (see Appendix A)
• Treatment naïve subjects or subjects who have received no more than one prior systemic treatment (immunotherapy, including interferon-alfa or interleukin-2 based therapy, chemotherapy, hormonal therapy or an investigational agent) for metastatic RCC.
• Eastern Cooperative Oncology Group performance status of 0 or 1, and life expectancy ≥ 3 months
• If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment
• Willingness to provide archival paraffin embedded tumor tissue, if available.
• Ability to give written informed consent and comply with protocol requirements

You may not qualify if…

• Any prior vascular endothelial growth factor (VEGF)-directed therapy including VEGF antibody (eg, bevacizumab), VEGF receptor tyrosine kinase inhibitor (eg, sunitinib, sorafenib, axitinib, pazopanib, etc.), VEGF trap (eg, aflibercept), or any other agent or investigational agent targeting the VEGF pathway.
• Any prior therapy with an agent targeting the mechanistic target of rapamycin pathway (eg, temsirolimus, everolimus, etc)
• Primary central nervous system (CNS) malignancies or CNS metastases; subjects with previously treated brain metastasis will be allowed if the brain metastasis have been stable without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
• Any of the following hematologic abnormalities:
• Hemoglobin < 9.0 g/dL
• Absolute neutrophil count (ANC) < 1500 per mm3
• Platelet count < 100,000 per mm3
• International Normalized Ratio >1.5 or partial thromboplastin time >1.5 × upper limit of normal (ULN)
• Any of the following serum chemistry abnormalities:
• Total bilirubin > 1.5 × ULN (or > 2.5 × ULN for subjects with Gilbert's syndrome)
• Aspartate aminotransferase or alanine aminotransferase > 2.5 × ULN (or > 5 × ULN for subjects with liver metastasis)
• Alkaline phosphatase > 2.5 × ULN (or > 5 × ULN for subjects with liver or bone metastasis)
• Creatinine > 2.0 × ULN
• Proteinuria > 3+ by urinalysis or urine dipstick
• Significant cardiovascular disease, including:
• Active clinically symptomatic left ventricular failure.
• Uncontrolled hypertension: Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 24 hours apart.
• Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug.
• History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation)
• Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
• Coronary or peripheral artery bypass graft within 6 months of screening
• Non-healing wound, bone fracture, or skin ulcer.
• Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
• Serious/active infection or infection requiring parenteral antibiotics.
• Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.

Where it is running

• Southern Cancer Center — Mobile, Alabama, United States
• Providence Health and Services — Burbank, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• St. Francis Cancer Research Foundation — Beech Grove, Indiana, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Medical Oncology, LLC — Baton Rouge, Louisiana, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Cancer & Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
• North Mississippi Hematology & Oncology Associates, Ltd. — Tupelo, Mississippi, United States
• Comprehensive Cancer Centers of Nevada & US Oncology Research — Las Vegas, Nevada, United States
• Mary Hitchcock Memorial Hospital, NH — Lebanon, New Hampshire, United States
• University of North Carolina, Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• The Jones Clinic — Germantown, Tennessee, United States
• The West Clinic — Memphis, Tennessee, United States
• Texas Oncology-Austin North — Austin, Texas, United States
• Coastal Bend Cancer Center — Corpus Christi, Texas, United States
• Texas Oncology-Baylor, Charles A. Sammons Cancer Center — Dallas, Texas, United States
• BC Cancer Agency Vancouver Centre — Vancouver, British Columbia, Canada
• Juravinski Cancer Center — Hamilton, Ontario, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Sunnybrook Odette Cancer Center, Toronto — Toronto, Ontario, Canada
• Montreal General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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