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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)

This study has been terminated.
(low enrollment)
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01745367
First received: December 6, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Triple Negative Breast Cancer
Drug: Tivozanib Hydrochloride
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by AVEO Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: approximately 48 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: approximately 48 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: approximately 48 months ] [ Designated as safety issue: No ]
  • Number of subjects with AEs and SAEs [ Time Frame: approximately 48 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Gene signature for potential predictiveness of response to treatment with tivozanib hydrochloride [ Time Frame: Baseline (approximately 2 cycles) ] [ Designated as safety issue: No ]

Estimated Enrollment: 147
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745367

  Show 54 Study Locations
Sponsors and Collaborators
AVEO Pharmaceuticals, Inc.
Astellas Pharma Inc
  More Information

Additional Information:
No publications provided

Responsible Party: AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01745367     History of Changes
Other Study ID Numbers: AV-951-12-204, 2012-003507-35
Study First Received: December 6, 2012
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration
Bahamas: BNDA
Canada: Health Canada
Italy: Ministry of Health, Agenzia Italiana del Farmaco (AIFA)
Spain: Área de Ensayos Clínicos, Subdirección General de Medicamentos de Uso Humano, Unidad de Registro y Tasas de la AEMPS
Ukraine: Ukraine Ministry of Health
Poland: Main Pharmaceutical Inspectorate
South Korea: KFDA
Germany: BfArM
Taiwan: Taiwan Food and Drug Administration
Australia: Therapeutic Goods Association

Keywords provided by AVEO Pharmaceuticals, Inc.:
Tivozanib hydrochloride
triple negative breast cancer
paclitaxel
pharmacokinetics
biomarkers
metastatic breast cancer
mBC
TNBC

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014