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A Trial of Tivozanib (AV-951) in Combination With Capecitabine (Xeloda®) in Subjects With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Trial of Tivozanib (AV-951) in Combination With Capecitabine (Xeloda®) in Subjects With Advanced Solid Tumors

A Phase 1b, Open-Label, Dose-Escalating Trial of Tivozanib (AV-951) in Combination With Capecitabine (Xeloda®) in Subjects With Advanced Solid Tumors

NCT01306630•AVEO Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, multi-center, dose-finding study of tivozanib administered in combination with capecitabine. During the dose-escalation portion, sequential cohorts of subjects with advanced solid tumors will be enrolled in order to establish the maximum tolerated dose (MTD). If the MTD is not reached, the recommended Phase 2 dose (RP2D) will be determined. In the expansion cohort, subjects with locally advanced or metastatic breast or colon cancer will be enrolled at MTD (or RP2D) to further evaluate safety and activity of this combination in these tumor types.

Detailed Description

This is a Phase Ib, open-label, multi-center, dose-escalation study of orally administered tivozanib in combination with capecitabine to approximately 24 subjects with advanced solid tumors and, in the expanded MTD cohort, subjects with locally advanced or metastatic breast or colorectal cancer. This study is designed to evaluate the safety, tolerability, dose-limiting toxicities, maximum tolerated dose, pharmacokinetic, and antineoplastic activity. The number of cohorts evaluated and the maximum doses to be administered will depend upon the observed tolerability. Dose level "0", tivozanib HCl 1.5 mg and capecitabine 1000 mg/m² BID, is the starting dose level. Once assigned to a cohort, each subject will continue to be treated at the same dose level and schedule throughout the course of the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 years or older, of either sex, and of any race.
•2. Histologically or cytologically confirmed solid tumor malignancy.
•3. Dose escalation cohorts: Advanced solid tumor malignancy (locally advanced or metastatic) that has recurred or progressed following standard therapy or for which no standard therapy currently exists, or for which subject is not a candidate for - standard therapy, or is unwilling to undergo standard therapy.
•4. MTD expansion cohort: Subjects must have locally advanced or metastatic breast or colorectal cancer with or without prior systemic therapy.
•5. ECOG performance ≤ 2 (Appendix B) and life expectancy ≥ 3 months.
•6. Disease that is not amenable to curative surgical intervention, due to either non-resectability of the tumor or medical contraindications.
•7. Subjects enrolled in the MTD expansion cohort must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0.
•8. At least 4 weeks since :
•• Vascular endothelial growth factor (VEGF) or VEGF receptor directed therapy
•* Chemotherapy (6 weeks since prior mitomycin C or nitrosoureas)
+13 more criteria

Exclusion Criteria

•1\. Primary CNS malignancies or CNS metastases; subjects with previously treated brain metastasis will be allowed if the brain metastasis has been stable without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery). Subjects with symptoms of CNS metastases or history must have a CT or MRI scan including the brain during Screening.
•2\. 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. Note: Initiation or adjustment of antihypertensive medication(s) is permitted during the screening period, in order to control a subject's BP prior to initiating treatment. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The SBP / DBP values from each blood pressure assessment must be ≤ 140/90 mmHg in order for a subject to be eligible for the study
•* Myocardial infarction, severe 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
•* History of coronary or peripheral artery bypass graft within 6 months
•3\. Significant thromboembolic or vascular disorders within 6 months prior to first dose of study drug; this does NOT include catheter-related thrombosis. Significant thromboembolic or vascular disorders include but are not limited to:
•* Deep vein thrombosis
+29 more criteria

Locations (3)

Scottsdale, Arizona, United States

Fort Myers, Florida, United States

Nashville, Tennessee, United States

Key Dates

Start Date

November 1, 2010

Primary Completion Date

January 1, 2014

Completion Date

January 1, 2014

Last Updated

January 27, 2014

Enrollment

ESTIMATED participants

Conditions

Advanced Solid TumorsLocally Advanced or Metastatic Breast or Colorectal Cancer

Interventions

tivozanib (AV-951) and capecitabine (Xeloda®)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Trial of Tivozanib (AV-951) in Combination With Capecitabine (Xeloda®) in Subjects With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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