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This is a Phase 1b/2, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of B-701 plus docetaxel versus placebo plus docetaxel in the treatment of locally advanced or metastatic urothelial cell carcinoma in subjects who have relapsed after, or are refractory to standard therapy.

Lead-In Phase Primary Objectives To determine an acceptable maximum tolerated dose (MTD) of B-701 plus docetaxel in subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. To evaluate the safety and efficacy of B-701 in combination with docetaxel and B-701 monotherapy in advanced UCC with FGFR3 genomic aberrations. Randomized Phase Primary Objective To evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel in the treatment of subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy which has not included a taxane, as measured by PFS. Secondary Objectives To evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel in the treatment of subjects with UCC as measured by objective response rates (ORR), disease control rate (DCR), duration of objective response (DOR), overall survival (OS), and quality of life (QOL). To evaluate the safety and tolerability of B-701 plus docetaxel compared with placebo plus docetaxel in the treatment of subjects with UCC as measured by adverse events (AEs), physical examination, laboratory, and electrocardiogram (ECG) results. To study the association between the level of FGFR3 expression, the presence of FGFR3 mutations or fusions, as well as other potential biomarkers (e.g., genetic alterations in other cancer-related genes), in primary tumors or metastases, with efficacy and/or AE outcomes. Exploratory Objectives To study associations of biomarkers such as urinary matrix metalloproteinase-1 (MMP-1) and urinary pro-matrix metalloproteinase-10 (pro-MMP-10) with efficacy and/or AE outcomes.

Lead-In Phase Primary Objectives To determine an acceptable maximum tolerated dose (MTD) of B-701 plus docetaxel in subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. To evaluate the safety and efficacy of B-701 in combination with docetaxel and B-701 monotherapy in advanced UCC with FGFR3 genomic aberrations. Randomized Phase Primary Objective To evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel in the treatment of subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy which has not included a taxane, as measured by PFS. Secondary Objectives To evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel in the treatment of subjects with UCC as measured by objective response rates (ORR), disease control rate (DCR), duration of objective response (DOR), overall survival (OS), and quality of life (QOL). To evaluate the safety and tolerability of B-701 plus docetaxel compared with placebo plus docetaxel in the treatment of subjects with UCC as measured by adverse events (AEs), physical examination, laboratory, and electrocardiogram (ECG) results. To study the association between the level of FGFR3 expression, the presence of FGFR3 mutations or fusions, as well as other potential biomarkers (e.g., genetic alterations in other cancer-related genes), in primary tumors or metastases, with efficacy and/or AE outcomes. Exploratory Objectives To study associations of biomarkers such as urinary matrix metalloproteinase-1 (MMP-1) and urinary pro-matrix metalloproteinase-10 (pro-MMP-10) with efficacy and/or AE outcomes.