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A Phase 2 Randomized, Double-Blind, Crossover, Controlled, Multi-Center Subject Preference Study of Tivozanib Hydrochloride Versus Sunitinib in the Treatment of Subjects With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Renal Cell Carcinoma

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Trial Information

A Phase 2 Randomized, Double-Blind, Crossover, Controlled, Multi-Center Subject Preference Study of Tivozanib Hydrochloride Versus Sunitinib in the Treatment of Subjects With Metastatic Renal Cell Carcinoma


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects who prefer tivozanib hydrochloride or sunitinib

Outcome Time Frame:

Up to 25 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

AV-951-12-205

NCT ID:

NCT01673386

Start Date:

July 2012

Completion Date:

January 2014

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Tivozanib hydrochloride
  • renal cell carcinoma
  • subject preference
  • quality of life
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Albany, Georgia  31701
Fountain Valley, California  92708
Albany, New York  12208
Cleveland, Ohio  44195
Austin, Texas  78705
Metairie, Louisiana  70006
Boston, Massachusetts  
Eugene, Oregon  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Charleston, South Carolina