A Phase 2 Study of B-701 in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma

Description

This is a phase 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.

Study Start Date

June 2015

Estimated Completion Date

December 2018

Interventions

  • Drug: B-701
  • Drug: placebo
  • Drug: Docetaxel

Specialties

  • Urology: Oncology,Prostate
  • Oncology: Pharmacology/Therapy,Renal/Urologic
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Carcinoma
  • Urinary Bladder Diseases

Study ID

BioClin Therapeutics, Inc. -- B-701-U21

Status

Unknown

Trial ID

NCT02401542

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

211

Sponsor

BioClin Therapeutics, Inc.

Key

Inclusion Criteria

  • Provide tumor tissue obtained within 18 months of enrollment of suitable quality and quantity and to demonstrate FGFR3 positive tumor by IHC. For subjects participating in the Randomized Phase only, if suitable archival tissue is unavailable, then a core biopsy of tumor tissue (metastatic or primary) must be obtained prior to randomization
  • Stage IV, locally advanced or metastatic urothelial bladder cancer or transitional cell carcinoma arising in another location of the urinary tract, including urethra, ureter, and renal pelvis
  • Relapsed after or are refractory to one or two prior lines of chemotherapy which have not included a taxane platinum agent, as long as a platinum agent is not contraindicated for the subject (i.e., if a platinum agent is contraindicated for a subject, the one or two prior regimen need not have included a platinum agent)
  • Measurable disease according to RECIST v1.1 criteria
  • ? 18 years old
  • ECOG 0 or 1 Main

Exclusion Criteria

  • Prior anti-cancer therapy within 4 weeks prior to Cycle 1, Day 1
  • Weight > 100kg
  • Clinically significant comorbid medical conditions or lab abnormalities

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
The DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles David Flanagan 617-582-8313 David_Flanagan@dfci.harvard.edu
Washington University School of Medicine - St. Louis, Missouri 1,039.5 miles Suzanne Shaffer 314-747-1343 sshaffer@dom.wustl.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Clinical Trials Referral Office 855-776-0015 None

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