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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01745367
• Date of registration: 06/12/2012
• Prospective Registration: No
• Primary sponsor: AVEO Pharmaceuticals, Inc.
• Public title: Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer BATON-BC
• 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
• Date of first enrolment: November 2012
• Target sample size: 30
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01745367
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Bahamas, Canada, Germany, Ghana, Italy, Korea, Republic of, Spain, Taiwan, Thailand, Ukraine, United States

Contacts

• Name: Michael Needle
• Affiliation: AVEO Pharmaceuticals, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Triple Negative Breast Cancer

Intervention(s)

Drug: paclitaxel

Drug: Placebo

Drug: Tivozanib Hydrochloride

Primary Outcome(s)

Comparison of Progression-free Survival (PFS) of Subjects [Time Frame: approximately 24 months]

Secondary Outcome(s)

Safety and Tolerability of Tivozanib Hydrochloride in Combination With Paclitaxel vs Placebo in Combination With Paclitaxel [Time Frame: approximately 24 months]

Comparison of Objective Response Rate (ORR) and Duration of Response (DoR) of Subjects [Time Frame: approximately 24 months]

Comparison of Overall Survival (OS) of Subjects [Time Frame: approximately 24 months]

Pharmacokinetics (PK) of Tivozanib Hydrochloride and Paclitaxel When Administered in Combination [Time Frame: approximately 24 months]

Identification of Hypoxia Gene Signature [Time Frame: 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]

Measurement of Subjects' Quality of Life (QoL) [Time Frame: approximately 24 months]

Secondary ID(s)

2012-003507-35

AV-951-12-204

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Astellas Pharma Inc

Results

• Results available: Yes
• Date Posted: 27/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01745367