Tivozanib Hydrochloride in Combination With Paclitaxel Versus Placebo With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (BATON-BC)
|ClinicalTrials.gov Identifier: NCT01745367|
Recruitment Status : Terminated (low enrollment)
First Posted : December 10, 2012
Last Update Posted : June 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: Tivozanib Hydrochloride Drug: paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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|
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745367
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