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

Metastatic Renal Cell Carcinoma Clinical Trial

— TAURUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01673386
• Other study ID #: AV-951-12-205
• Status: Terminated
• Phase: Phase 2
• Start date: July 2012
• Est. completion date: January 2014

Study information

• Verified date: October 2020
• Source: AVEO Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (RCC).

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 Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG score (0 vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1 of 2 treatment arms. The study consists of two 12-week treatment periods with a 1-week washout in between. Subjects will receive double-blind (over-encapsulated) tivozanib hydrochloride and sunitinib sequentially. The study is designed to compare subject treatment preference, as well as overall safety and tolerability, frequency of dose modifications and kidney-specific health outcomes/QoL.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• Tivozanib

• Sunitinib

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AVEO Pharmaceuticals, Inc.	Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Up to 25 weeks
Secondary	Number of Subjects With AEs and SAEs	Number of subjects with serious and non-serious adverse events.	Up to 25 weeks
Secondary	Number of Subjects With Dose Reductions	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Up to 25 weeks
Secondary	Number of Subjects With Dose Interruptions	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Up to 25 weeks
Secondary	Number of Subjects With Grade 3/4 Hematology Abnormalities	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Up to 25 weeks
Secondary	Number of Subjects With Grade 3/4 Chemistry Abnormalities	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Up to 25 weeks
Secondary	Number of Subjects With Grade 3/4 Coagulation Abnormalities	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Up to 25 weeks
Secondary	Number of Subjects With Grade 3/4 Urinalysis Abnormalities	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Up to 25 weeks
Secondary	Number of Subjects With Grade 3/4 Thyroid Function Abnormalities	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Up to 25 weeks
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Secondary	Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS)	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Secondary	Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
Secondary	Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)	The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.	Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment

External Links

•   Aveo Pharmaceuticals, Inc. official web page