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COMPLETEDPHASE3

A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma

A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)

NCT01030783•AVEO Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

Detailed Description

This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib. Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib and stratified by geographic region (North America/Western Europe, Central/Eastern Europe, or rest of the world); number of prior treatments (0 or 1); and number of metastatic sites/organs involved (1 or ≥ 2).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥ 18-years of age.
•2. Subjects with recurrent or metastatic RCC.
•3. Subjects must have undergone prior nephrectomy (complete or partial) for excision of the primary tumor.
•4. Histologically or cytologically confirmed RCC with a clear cell component (subjects with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, mixed tumor containing predominantly sarcomatoid cells, and unclassified RCC are excluded).
•5. Measurable disease per the RECIST criteria Version 1.0.
•6. 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. Postoperative or adjuvant systemic therapy will not be counted as a prior therapy unless recurrence is detected within 6 months of completion of treatment, in which case it will be counted as a prior therapy for metastatic disease.
•7. ECOG performance status of 0 or 1, and life expectancy ≥ 3 months.
•8. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment.
•9. Ability to give written informed consent and comply with protocol requirements.

Exclusion Criteria

•1. Any prior 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.
•2. Any prior therapy with an agent targeting the mTOR pathway (eg, temsirolimus, everolimus, etc)
•3. Primary 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).
•4. Any hematologic abnormalities (as noted in the protocol).
•5. Any serum chemistry abnormalities (as noted in the protocol).
•6. Significant cardiovascular disease.
•7. Non-healing wound, bone fracture, or skin ulcer.
•8. 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.
•9. Serious/active infection or infection requiring parenteral antibiotics.
•10. Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.
+10 more criteria

Locations (86)

Site 185

Los Angeles, California, United States

Site 180

Gainesville, Florida, United States

Site 184

Orlando, Florida, United States

Site 182

Minneapolis, Minnesota, United States

Site 186

New York, New York, United States

Site 187

Dallas, Texas, United States

Site 102

Sante Fe, Argentina

Site 403

Plovdiv, Bulgaria

Site 404

Sofia, Bulgaria

Site 400

Sofia, Bulgaria

Key Dates

Start Date

December 1, 2009

Primary Completion Date

July 1, 2012

Completion Date

June 1, 2013

Last Updated

October 28, 2019

Enrollment

517

ACTUAL participants

Conditions

Advanced Renal Cell Carcinoma

Interventions

tivozanib (AV-951)

DRUG

Sorafenib

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: October 28, 2019Data 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 Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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