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

Trial Profile

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

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 07 Dec 2017

At a glance

  • Drugs B 701 (Primary) ; Docetaxel
  • Indications Bladder cancer; Urogenital cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors BioClin Therapeutics
  • Most Recent Events

    • 06 Jun 2017 According to preliminary results presented at the 53rd Annual Meeting of the American Society of Clinical Oncology, the study protocol has been amended to add cohorts 2 (B-701+Docetaxel) and 3 (B-701) (n=20 patients/cohort) for patients with FGFR3 mut/fus+ tumors only.
    • 06 Jun 2017 Preliminary results (n=19, as of 20 Jan 2017, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 06 Jan 2017 Planned number of patients changed from 211 to 261.
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