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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01745367




Registration number
NCT01745367
Ethics application status
Date submitted
6/12/2012
Date registered
10/12/2012

Titles & IDs
Public title
Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer
Scientific 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
Secondary ID [1] 0 0
2012-003507-35
Secondary ID [2] 0 0
AV-951-12-204
Universal Trial Number (UTN)
Trial acronym
BATON-BC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).

Experimental: Tivo 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).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of Progression-free Survival (PFS) of Subjects
Timepoint [1] 0 0
approximately 24 months
Secondary outcome [1] 0 0
Comparison of Objective Response Rate (ORR) and Duration of Response (DoR) of Subjects
Timepoint [1] 0 0
approximately 24 months
Secondary outcome [2] 0 0
Comparison of Overall Survival (OS) of Subjects
Timepoint [2] 0 0
approximately 24 months
Secondary outcome [3] 0 0
Safety and Tolerability of Tivozanib Hydrochloride in Combination With Paclitaxel vs Placebo in Combination With Paclitaxel
Timepoint [3] 0 0
approximately 24 months
Secondary outcome [4] 0 0
Pharmacokinetics (PK) of Tivozanib Hydrochloride and Paclitaxel When Administered in Combination
Timepoint [4] 0 0
approximately 24 months
Secondary outcome [5] 0 0
Identification of Hypoxia Gene Signature
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Measurement of Subjects' Quality of Life (QoL)
Timepoint [6] 0 0
approximately 24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- Port Macquarie
Recruitment hospital [2] 0 0
- Woodville South
Recruitment hospital [3] 0 0
- Bentleigh
Recruitment hospital [4] 0 0
- Newcastle
Recruitment hospital [5] 0 0
- South Brisbane
Recruitment hospital [6] 0 0
- St Leonards
Recruitment postcode(s) [1] 0 0
- Port Macquarie
Recruitment postcode(s) [2] 0 0
- Woodville South
Recruitment postcode(s) [3] 0 0
3204 - Bentleigh
Recruitment postcode(s) [4] 0 0
- Newcastle
Recruitment postcode(s) [5] 0 0
- South Brisbane
Recruitment postcode(s) [6] 0 0
- St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
North Dakota
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
South Dakota
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
Bahamas
State/province [16] 0 0
Nassau
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Saint John
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Cologne
Country [23] 0 0
Germany
State/province [23] 0 0
Hanau am Main
Country [24] 0 0
Germany
State/province [24] 0 0
Leipzig
Country [25] 0 0
Germany
State/province [25] 0 0
Muenster
Country [26] 0 0
Germany
State/province [26] 0 0
Tuebingen
Country [27] 0 0
Italy
State/province [27] 0 0
Avellino
Country [28] 0 0
Italy
State/province [28] 0 0
Milano
Country [29] 0 0
Italy
State/province [29] 0 0
Roma
Country [30] 0 0
Italy
State/province [30] 0 0
Torino
Country [31] 0 0
Italy
State/province [31] 0 0
Viterbo
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Malaga
Country [36] 0 0
Spain
State/province [36] 0 0
Sevilla
Country [37] 0 0
Taiwan
State/province [37] 0 0
Kaohsiung
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taipei
Country [39] 0 0
Ukraine
State/province [39] 0 0
Dnipropetrovsk
Country [40] 0 0
Ukraine
State/province [40] 0 0
Donetsk
Country [41] 0 0
Ukraine
State/province [41] 0 0
Uzhhorod
Country [42] 0 0
Ukraine
State/province [42] 0 0
Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AVEO Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Astellas Pharma Inc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Needle
Address 0 0
AVEO Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01745367