Tivozanib Hydrochloride in Combination With Paclitaxel Versus Placebo With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (BATON-BC)
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.
Triple Negative Breast Cancer
Drug: Tivozanib Hydrochloride
|Study Design:||Allocation: Randomized
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|
- Progression Free Survival [ Time Frame: approximately 24 months ]
- Objective Response Rate [ Time Frame: approximately 48 months ]
- Duration of Response [ Time Frame: approximately 48 months ]
- Overall Survival [ Time Frame: approximately 48 months ]
- Number of subjects with AEs and SAEs [ Time Frame: approximately 48 months ]
- 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 ]
- Gene signature for potential predictiveness of response to treatment with tivozanib hydrochloride [ Time Frame: Baseline (approximately 2 cycles) ]
|Study Start Date:||November 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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: 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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745367
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