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Trial record 1 of 1 for:    NCT01745367
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Tivozanib Hydrochloride in Combination With Paclitaxel Versus Placebo With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (BATON-BC)

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ClinicalTrials.gov Identifier: NCT01745367
Recruitment Status : Terminated (low enrollment)
First Posted : December 10, 2012
Last Update Posted : June 23, 2015
Astellas Pharma Inc
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.

Brief Summary:

This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.

Patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or placebo and weekly paclitaxel.

Subjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance score (0 vs 1) and line of treatment (first vs second).

All subjects will be evaluated for progression free survival and overall survival as well as safety and tolerability. Biomarker and pharmacokinetic (PK) analysis are also included in study. This study will determine whether tivozanib hydrocholoride combined with weekly paclitaxel improves clinical outcomes in patients with triple negative breast cancer.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: Tivozanib Hydrochloride Drug: paclitaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2012
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Placebo in combination with paclitaxel
Placebo orally once daily on a 3 weeks on/1 week off schedule with 90 mg/m2 of paclitaxel administered intravenously 3 weeks on (Day 1, Day 8 and Day 15)/1 week off (4 weeks = 1 Cycle).
Drug: paclitaxel
Experimental: Tivozanib Hydrochloride in combination with paclitaxel
1.5 mg tivozanib hydrochloride orally once daily on a 3 weeks on/1 week off schedule with 90 mg/m2 of paclitaxel administered intravenously 3 weeks on (Day 1, Day 8 and Day 15)/1 week off (4 weeks = 1 Cycle).
Drug: Tivozanib Hydrochloride Drug: paclitaxel

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: approximately 24 months ]

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: approximately 48 months ]
  2. Duration of Response [ Time Frame: approximately 48 months ]
  3. Overall Survival [ Time Frame: approximately 48 months ]
  4. Number of subjects with AEs and SAEs [ Time Frame: approximately 48 months ]
  5. PK profile of tivozanib hydrochloride in combination with paclitaxel. [ Time Frame: Cycle 1, Day 1, Day 8, Day 15 and Cycle 2, Day 1, pre- and post-dose ]
  6. Gene signature for potential predictiveness of response to treatment with tivozanib hydrochloride [ Time Frame: Baseline (approximately 2 cycles) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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:

  • More than 1 prior systemic chemotherapy for treatment of locally recurrent or metastatic breast cancer (neoadjuvant and adjuvant therapy is allowed provided the subject did not progress within 12 months of taxane based therapy
  • Prior treatment with VEGF pathway targeted agent
  • Major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first dose of study drug
  • Known history of central nervous system metastasis (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745367

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Sponsors and Collaborators
AVEO Pharmaceuticals, Inc.
Astellas Pharma Inc

Additional Information:
Responsible Party: AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01745367     History of Changes
Other Study ID Numbers: AV-951-12-204
2012-003507-35 ( EudraCT Number )
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by AVEO Pharmaceuticals, Inc.:
Tivozanib hydrochloride
triple negative breast cancer
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action