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

NCT01673386 | Terminated Phase 2 Results

• 1 other identifier: AV-951-12-205
• Study Type: interventional
• Target: 58
• Locations: 7 countries
• Sites: 38

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 (RCC).

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Tivozanib hydrochloride; renal cell carcinoma; subject preference; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Number of Subjects With AEs and SAEs

  Up to 25 weeks

• Number of Subjects With Dose Reductions

  Up to 25 weeks

• Number of Subjects With Dose Interruptions

  Up to 25 weeks

• Number of Subjects With Grade 3/4 Hematology Abnormalities

  Up to 25 weeks

• Number of Subjects With Grade 3/4 Chemistry Abnormalities

  Up to 25 weeks

Study Arms (2)

Tivozanib Hydrochloride

EXPERIMENTAL

1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks.

Drug: Tivozanib

Sunitinib

ACTIVE COMPARATOR

50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks.

Drug: Sunitinib

Interventions

Tivozanib DRUG

Also known as: Tivozanib Hydrochloride

Tivozanib Hydrochloride

Sunitinib DRUG

Also known as: Sutent

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AVEO Pharmaceuticals, Inc.: lead
• Astellas Pharma Inc: collaborator

Study Sites (38)

Unknown Facility

Los Angeles, California, 90001, United States

Location

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Albany, Georgia, 31701, United States

Location

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Atlanta, Georgia, 30301, United States

Location

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Chicago, Illinois, 60007, United States

Location

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Indianapolis, Indiana, 46077, United States

Location

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Shreveport, Louisiana, 71101, United States

Location

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Worcester, Massachusetts, 01601, United States

Location

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Minneapolis, Minnesota, 55111, United States

Location

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New York, New York, 10001, United States

Location

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Columbus, Ohio, 43004, United States

Location

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Portland, Oregon, 97035, United States

Location

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Charleston, South Carolina, 29401, United States

Location

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Myrtle Beach, South Carolina, 29572, United States

Location

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San Antonio, Texas, 78006, United States

Location

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Madison, Wisconsin, 53558, United States

Location

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Antwerp, Belgium

Location

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Brussels, Belgium

Location

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Bordeaux, France

Location

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Caen, France

Location

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Lyon, France

Location

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Paris, France

Location

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Berlin, Germany

Location

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Hamburg, Germany

Location

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Hanover, Germany

Location

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Heidelberg, Germany

Location

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Munich, Germany

Location

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Aviano, Italy

Location

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Pavia, Italy

Location

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Rome, Italy

Location

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Barcelona, Spain

Location

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Madrid, Spain

Location

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Pamplona, Spain

Location

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Valencia, Spain

Location

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Glasgow, Scotland, United Kingdom

Location

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Swansea, Wales, United Kingdom

Location

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Cambridge, United Kingdom

Location

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London, United Kingdom

Location

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Manchester, United Kingdom

Location

Related Links

• Aveo Pharmaceuticals, Inc. official web page

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

tivozanib; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The Sponsor terminated Study AV-951-12-205 before enrollment was completed, following the negative decision of the US FDA.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: AVEO Pharmaceuticals, Inc.

Clinical@aveooncology.com

857-400-0101

Study Officials

• Michael Needle, MD

  AVEO Pharmaceuticals, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 27, 2020
• Results First Posted: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); FR (4); BE (2); US (15); GB (5); DE (5); IT (3)