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

NCT01030783 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2019-10-28

Study results available
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Summary

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.

Conditions

  • Advanced Renal Cell Carcinoma

Interventions

DRUG

tivozanib (AV-951)

Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.

DRUG

Sorafenib

Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.

Sponsors & Collaborators

  • AVEO Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert J. Motzer, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-07-31
Completion
2013-06-30

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • France
  • Hungary
  • India
  • Italy
  • Poland
  • Romania
  • Russia
  • Serbia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01030783 on ClinicalTrials.gov