AzTrials
AzTrials

Triple Negative Breast CancerPhase 2BATON-BCNCT01745367

Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer

A Phase 2 study testing Tivozanib Hydrochloride and paclitaxel in people with Triple Negative Breast Cancer, run by AVEO Pharmaceuticals, Inc. at 54 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Tivozanib Hydrochloride and paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
54 sitesin 10 countries
Study dates
Nov 2012to Jun 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

54 sites in 10 countries.

54 sites in 10 countries

United States20 sites

  • Study site

    Atlanta, Georgia, 30301

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Birmingham, Alabama, 35005

  • Study site

    Boston, Massachusetts, 01841

  • Study site

    Chapel Hill, North Carolina, 27514

  • Study site

    Charleston, South Carolina, 02129

  • Study site

    Chicago, Illinois, 60007

  • Study site

    Dallas, Texas, 75001

  • Study site

    Fargo, North Dakota, 58102

  • Study site

    Fort Wayne, Indiana, 46774

  • Study site

    Galveston, Texas, 77550

  • Study site

    Indianapolis, Indiana, 46077

  • Study site

    Jacksonville, Florida, 32034

  • Study site

    Memphis, Tennessee, 37501

  • Study site

    Miami, Florida, 33018

  • Study site

    New York, New York, 10001

  • Study site

    Oak Lawn, Illinois, 60456

  • Study site

    Sioux Falls, South Dakota, 57101

  • Study site

    St Louis, Missouri, 63101

  • Study site

    The Bronx, New York, 10453

Other trials in United States

Australia6 sites

  • Study site

    Bentleigh, Victoria, 3204

  • Study site

    Newcastle

  • Study site

    Port Macquarie, New South Wales

  • Study site

    South Brisbane

  • Study site

    St Leonards

  • Study site

    Woodville South, South Australia

Other trials in Australia

Germany6 sites

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Hanau, 63454

  • Study site

    Leipzig

  • Study site

    Münster

  • Study site

    Tübingen

Other trials in Germany

Canada5 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Saint John

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Italy5 sites

  • Study site

    Avellino

  • Study site

    Milan

  • Study site

    Roma

  • Study site

    Torino

  • Study site

    Viterbo

Other trials in Italy

Spain4 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Seville

Other trials in Spain

Ukraine4 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Donetsk

  • Study site

    Uzhhorod

  • Study site

    Vinnytsia

Other trials in Ukraine

Taiwan2 sites

  • Study site

    Kaohsiung City

  • Study site

    Taipei

Other trials in Taiwan

South Korea1 site

  • Study site

    Seoul

Other trials in South Korea

The Bahamas1 site

  • Study site

    Nassau

About this study

Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Study Comparing Tivozanib Hydrochloride in Combination With Paclitaxel v Placebo in Combination With Paclitaxel in Locally Recurrent and/or Metastatic Triple Negative Breast Cancer

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.

Read the detailed description

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.

Being tested
Tivozanib Hydrochloride, paclitaxel, Placebo
Keywords
Tivozanib hydrochloride, triple negative breast cancer, paclitaxel, pharmacokinetics, biomarkers, metastatic breast cancer, mBC, TNBC
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tivozanib HydrochlorideDrug

    Also called Tivozanib

  • paclitaxelDrug

    Also called PTX

  • PlaceboDrug

Study groups in NCT01745367
Study groupRoleWhat they receive
Placebo in combination with paclitaxelActive comparatorPlacebo 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).
Receives: Drug: paclitaxel; Drug: Placebo
Tivo in combination with paclitaxelExperimental1.5 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).
Receives: Drug: Tivozanib Hydrochloride; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of Progression-free Survival (PFS) of Subjects

    PFS is defined as the time from randomization to progressive disease (PD) or death. The PFS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.

    Measured: approximately 24 months

Secondary outcomes (6)

  1. Comparison of Objective Response Rate (ORR) and Duration of Response (DoR) of Subjects

    ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. DoR is defined as the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. The ORR and DoR comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.

    Measured: approximately 24 months

  2. Comparison of Overall Survival (OS) of Subjects

    OS measures how long subjects, who undergo a certain treatment regimen, live compared to subjects who are in a control group (i.e., taking either another drug or an inactive treatment, known as a placebo). OS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.

    Measured: approximately 24 months

  3. Safety and Tolerability of Tivozanib Hydrochloride in Combination With Paclitaxel vs Placebo in Combination With Paclitaxel

    Number of subjects with serious and non-serious adverse events.

    Measured: approximately 24 months

  4. Pharmacokinetics (PK) of Tivozanib Hydrochloride and Paclitaxel When Administered in Combination

    PK is defined as the study of the bodily absorption, distribution, metabolism, and excretion of drugs.

    Measured: approximately 24 months

  5. Identification of Hypoxia Gene Signature

    Evaluation of hypoxia gene signature as a predictive biomarker of tivozanib hydrochloride response and establish the optimal cut-off to identify biomarker positive and negative subgroups. The genes comprising the hypoxia gene signature was analyzed in tumor tissue from subjects.

    Measured: Cycle 1, Day 1: Pre-dose and 2, 4 and 24 hours post dose; Cycle 1, Day 8: Pre-dose; Cycle 1, Day 21: Pre-dose and 2, 4, 24, 48, and 96 hours post dose; Cycle 2 (Day 1): Pre-dose

  6. Measurement of Subjects' Quality of Life (QoL)

    The Functional Assessment of Cancer Therapy-Breast (FACT-B) and Euro Quality of Life - 5 Dimensions (EQ-5D) questionnaires was used throughout the study to measure subjects' health-related QoL.

    Measured: approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionJun 2014
  4. Study completionJun 2014

Why it stopped: low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01745367
Sponsor's protocol ID
AV-951-12-204
Other IDs
2012-003507-35
Acronym
BATON-BC
Status last verified
Oct 2020
First submitted
6 Dec 2012
Last updated
27 Oct 2020
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tivozanib Hydrochloride and paclitaxel in people with Triple Negative Breast Cancer, run by AVEO Pharmaceuticals, Inc. at 54 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Australia, Germany, Canada, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Progression-free Survival (PFS) of Subjects (time frame: approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01745367.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in