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 is currently recruiting participants.
Verified April 2013 by AVEO Pharmaceuticals, Inc.
Sponsor:
AVEO Pharmaceuticals, Inc.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01745367
First received: December 6, 2012
Last updated: April 29, 2013
Last verified: April 2013
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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 who have not received prior systemic therapy for advanced disease.
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 prior neoadjuvant or adjuvant taxane therapy (yes vs no)
All subjects will be evaluated for progression free survival and overall survival as well as safety, tolerability and quality of life. 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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Paclitaxel
U.S. FDA Resources
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 ]
- Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) [ Time Frame: Baseline through End of Treatment (approximately 8 months) ] [ Designated as safety issue: No ]
- Change from baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) [ Time Frame: Baseline through End of Treatment (approximately 8 months) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 147 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 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:
- Any prior systemic chemotherapy for treatment of locally recurrent or metastatic breast cancer (neoadjuvant and adjuvant therapy is allowed provided the subject did not progress and that there is >6 months (>12 months for taxane based therapy) since end of treatment and first dose of study drug and any toxicities have resolved to ≤ Grade 1)
- Major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first dose of study drug
- Untreated central nervous system metastases (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745367
Show 44 Study Locations
Contacts
| Contact: Shaefali Agarwal, M.D | +001-617-299-5706 | sagarwal@aveooncology.com |
| Contact: Brooke Esteves, R.N | +001-617-299-5993 | besteves@aveooncology.com |
Show 44 Study LocationsSponsors 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: | April 29, 2013 |
| 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 Ghana: Ministry of Health Republic of Ghana South Korea: KFDA Thailand: Food and Drug Administration Thailand 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013