A Cardiac Safety Study of Tivozanib to Evaluate the Electrocardiogram and Pharmacokinetic-Electrocardiogram Dynamics in Subjects With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

The purpose of this study is to obtain QTc data, to assess the effects of tivozanib on ECG morphology, and to determine the pharmacokinetic pharmacodynamic (PK-PD) relationship between any observed changes in cardiac repolarization (defined by QTcF duration) and the serum concentration of tivozanib.

Key facts

Study ID

NCT01210846

Run by

AVEO Pharmaceuticals, Inc.

People needed

50

Starts

2010-10-01

Expected to finish

2011-07-01

Last updated by the study team

2011-09-26

Who can join

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

You may qualify if…

• Males or females, ≥18 years of age;
• Diagnosis of an advanced solid tumor malignancy with histological or cytological evidence;
• Advanced malignancy, metastatic or unresectable, that has recurred or progressed following standard therapy or failed standard therapy; or for which no standard therapy currently exists; or for which subject is not a candidate, or is unwilling to undergo standard therapy;
• Tumor is not currently amenable to curative surgical intervention;
• Recovery from the effects of any prior surgery, radiotherapy, or systemic antineoplastic therapy;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and life expectancy ≥ 3 months;
• Well controlled thyroid function, in the opinion of the Investigator;
• Able to comprehend and willing to sign an Informed Consent Form (ICF) and able to adhere to dose and visit schedule.

You may not qualify if…

• Women who are breast-feeding, pregnant, or intend to become pregnant;
• 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);
• Clinically significant cardiac disease (New York Heart Association class > 2) including unstable angina, acute myocardial infarction within 6 months of Day 1, congestive heart failure, or arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities, per Investigator judgment;
• 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;
• Baseline ECG, QTcF > 480 ms. If the screening QTcF is > 480 ms, this may be repeated once and if the QTcF is ≤ 480 ms the subject can be enrolled;
• Any of the following hematologic abnormalities:
• hemoglobin < 9.0 g/dL;
• Absolute neutrophil count < 1500 per mm3;
• platelet count < 100,000 per mm3;
• INR > 1.5 x upper limit of normal (ULN);
• Any of the following serum chemistry or urine abnormalities:
• total bilirubin > 1.5 × ULN (or > 2.5 × ULN for subjects with Gilbert's syndrome);
• AST or ALT > 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;
• 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 or antifungal therapy;
• Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug;
• Significant thromboembolic or vascular disorders or surgery within 6 months prior to administration of first dose of study drug, including but not limited to:
• deep vein thrombosis;
• pulmonary embolism;
• cerebrovascular accident or transient ischemic attack;
• peripheral arterial ischemia > Grade 2;

Where it is running

• TGEN Clinical Research Service at Scottsdale Healthcare — Scottsdale, Arizona, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Horizon Oncology Research, Inc. — Lafayette, Indiana, United States
• Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD and Janet Burroff MD APMC — Metairie, Louisiana, United States
• Associates in Oncology/Hematology — Rockville, Maryland, United States
• Oklahoma University Cancer Institute (OUCI) — Oklahoma City, Oklahoma, United States
• Tennessee Onocology — Nashville, Tennessee, United States
• Multicare Research Institute/Tacoma General Hospital — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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