Status:

TERMINATED

A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC

Lead Sponsor:

AVEO Pharmaceuticals, Inc.

Collaborating Sponsors:

Astellas Pharma Inc

Conditions:

Metastatic Renal Cell Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RC...

Detailed Description

This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Car...

Eligibility Criteria

Inclusion Criteria:

  • Unresectable mRCC
  • Histologically or cytologically confirmed RCC of any histology
  • Subjects with or without prior nephrectomy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Any prior systemic therapy for treatment of mRCC (including investigational or licensed drugs that target VEGF or VEGF receptors/pathway, or are mammalian target of rapamycin [mTOR] inhibitors)
  • Central nervous system malignancies or metastases
  • Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders
  • Significant serum chemistry or urinalysis abnormalities
  • Significant cardiovascular disease, including symptomatic left ventricular ejection fraction or baseline LVEF of ≤ institutional lower limit of normal, uncontrolled hypertension, myocardial infarction or severe angina within 6 months prior to administration of first dose of study drug, history of class III or IV congestive heart failure, or history of serious ventricular arrhythmia, cardiac arrhythmias, or coronary or peripheral bypass graft within 6 months of screening
  • Corrected QT interval (QTc) of >480 msec using Bazett's formula
  • Currently active second primary malignancy

Key Trial Info

Start Date :

July 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2014

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT01673386

Start Date

July 1 2012

End Date

January 1 2014

Last Update

October 27 2020

Active Locations (38)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 10 (38 locations)

1

Los Angeles, California, United States, 90001

2

Albany, Georgia, United States, 31701

3

Atlanta, Georgia, United States, 30301

4

Chicago, Illinois, United States, 60007