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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Multi-center Study Comparing Tivozanib Hydrochloride in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in the Treatment of Subjects With Locally Recurrent and/or Metastatic Triple Negative Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Triple Negative Breast Cancer

Thank you

Trial Information

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Multi-center Study Comparing Tivozanib Hydrochloride in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in the Treatment of Subjects With Locally Recurrent and/or Metastatic Triple Negative Breast Cancer


Inclusion Criteria:



- Locally recurrent or metastatic TNBC, defined as ER/PR <1%, HER2 0-1+, or 2+ with
negative FISH

- Measurable disease per RECIST version 1.1

- ECOG performance status of 0 or 1

- Confirmed available archival tumor tissue.

Exclusion Criteria:

- Any prior systemic chemotherapy for treatment of locally recurrent or metastatic
breast cancer (neoadjuvant and adjuvant therapy is allowed provided the subject did
not progress and that there is >6 months (>12 months for taxane based therapy) since
end of treatment and first dose of study drug and any toxicities have resolved to ≤
Grade 1)

- Major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first
dose of study drug

- Untreated central nervous system metastases (subjects with previously treated
(radiotherapy or surgery) brain metastasis that have been stable off steroids or
enzyme-inducing antiepileptic drugs for at least 3 months following prior treatment
may be enrolled)

- Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or
coagulation disorders

- Significant serum chemistry or urinalysis abnormalities

- Significant cardiovascular disease, including: uncontrolled hypertension; myocardial
infarction or unstable angina within 6 months prior to administration of first dose
of study drug; and symptomatic left ventricular dysfunction or baseline left
ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or ECHO.

- Severe peripheral neuropathy ≥ Grade 2

- Currently active second primary malignancy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

approximately 24 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

AV-951-12-204

NCT ID:

NCT01745367

Start Date:

November 2012

Completion Date:

January 2017

Related Keywords:

  • Triple Negative Breast Cancer
  • Tivozanib hydrochloride
  • triple negative breast cancer
  • paclitaxel
  • pharmacokinetics
  • biomarkers
  • metastatic breast cancer
  • mBC
  • TNBC
  • Breast Neoplasms

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Birmingham, Alabama  35294
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Indianapolis, Indiana  
Charleston, South Carolina  
Sioux Falls, South Dakota  
Bismarck, North Dakota  58501