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A Phase 1b/2 Study of B-701 in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by BioClin Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
BioClin Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02401542
First received: March 16, 2015
Last updated: July 13, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Locally Advanced or Metastatic Urothelial Cell Carcinoma Urinary Bladder Disease Urological Diseases Drug: B-701 Drug: Docetaxel Drug: placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BioClin Therapeutics, Inc.:

Primary Outcome Measures:
  • Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by progression-free survival (PFS) [ Time Frame: up to 3-4 years ]

Secondary Outcome Measures:
  • Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by objective response rates (ORR) [ Time Frame: up to 3-4 years ]
  • Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by disease control rate (DCR) [ Time Frame: up to 3-4 years ]
  • Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by duration of objective response (DOR) [ Time Frame: 3-4 years ]
  • Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by overall survival (OS) [ Time Frame: 3-4 years ]
  • Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by quality of life (QOL) [ Time Frame: 3-4 years ]
  • Safety and tolerability assessed through summaries of AEs [ Time Frame: 3-4 years ]
    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 AEs

  • Safety and tolerability assessed through summaries of physical examination findings [ Time Frame: 3-4 years ]
    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 physical examinations.

  • Safety and tolerability assessed through summaries of laboratory laboratory results [ Time Frame: 3-4 years ]
    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 laboratory results.

  • Safety and tolerability assessed through summaries of ECG results. [ Time Frame: 3-4 years ]
    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 electrocardiogram (ECG) results.

  • Evaluate FGFR3 Expression [ Time Frame: 3-4 years ]
    To study the association between the level of FGFR3 expression in primary tumors or metastases with efficacy and/or adverse event (AE) outcomes.

  • Evaluation of FGFR3 mutations or fusions in primary tumors or metastases [ Time Frame: 3-4 years ]
    To study the association between the presence of FGFR3 mutations or fusions in primary tumors or metastases with efficacy and/or adverse event (AE) outcomes.


Estimated Enrollment: 261
Study Start Date: June 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B-701 plus docetaxel
IV infusion B-701, 25 mg/kg plus docetaxel, 75 mg/m2 on day one of each 21-day cycle
Drug: B-701 Drug: Docetaxel
Placebo Comparator: Placebo plus docetaxel
IV infusion placebo plus docetaxel, 75 mg/m2 on day one of each 21-day cycle
Drug: Docetaxel Drug: placebo
Experimental: B-701
IV infusion B-701, 25 mg/kg
Drug: B-701

Detailed Description:
This is a Phase 1b/2, randomized, double-blind, placebo-controlled, multicenter, parallel-group, efficacy and safety study of B-701 plus docetaxel versus 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. This study is divided into 2 phases: Lead-In Phase and Randomized Phase; and the Lead-In Phase is divided into 3 cohorts. In Cohorts 1 and 2, all subjects will receive both B-701 plus docetaxel (unblinded). In Cohort 3, all subjects will receive B-701 only (unblinded). Subjects enrolling in Cohorts 2 and 3, as well as the Randomized Phase of the study, must have tumors with FGFR3 mutations or gene fusions.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Available tissue that was obtained at or after the time the usbject was found to have muscle invasive disease and is of suitable quality and quantity and to assess the FGFR3 status by genetic testing. 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 even if a blood sample sample was used to determine FGFR3 genetic status
  • 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 at least one prior line of chemotherapy which have not included a taxane (with the exception of Cohort 3 of the Lead-In Phase which will allow the enrollment of subjects with prior treatment with a taxane)
  • At least one prior chemotherapeutic regimen for advanced metastatic/recurrent disease, of which at least one regimen included a platinum agent (unless contraindicated)
  • Measurable disease according to RECIST v1.1 criteria
  • For Cohort 2, Cohort 3, and the Randomized Phase, tumor must be shown to have an FGFR3 mutation or gene fusion.

Main Exclusion Criteria:

  • Prior anti-cancer therapy within 4 weeks prior to Cycle 1, Day 1
  • Prior treatment with an inhibitor that is targeted primarily to FGFRs
  • Clinically significant comorbid medical conditions or lab abnormalities
  • History of major bleeding (requiring a blood transfusion ≥ 2 units) not related to a tumor within the past 12 months
  • History of clinically significant coagulation or platelet disorder in the past 12 months
  • Currently receiving anticoagulation treatment
  • Incomplete healing from wounds from prior surgery
  • Weight > 110kg
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02401542

Contacts
Contact: Sue Hirabayashi, MBA (510) 501-3713 shirabayashi@bioclintherapeutics.com
Contact: Tarah Bateman (925) 323-8181 tbateman@bioclintherapeutics.com

Locations
United States, California
Research Site Recruiting
Duarte, California, United States, 91010
Contact: BioClin Study Team       clin-ops@bioclintherapeutics.com   
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02215
Contact: BioClin Study Team       clin-ops@bioclintherapeutics.com   
United States, Minnesota
Research Site Recruiting
Rochester, Minnesota, United States, 55905
Contact: BioClin Study Team       clin-ops@bioclintherapeutics.com   
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110
Contact: BioClin Study Team       clin-ops@bioclintherapeutics.com   
United States, North Carolina
Research Site Recruiting
Chapel Hill, North Carolina, United States, 27599-7305
Contact: BioClin Study Team       clin-ops@bioclintherapeutics.com   
United States, Texas
Research Site Recruiting
Dallas, Texas, United States, 75390-9110
Contact: BioClin Study Team       clin-ops@bioclintherapeutics.com   
Sponsors and Collaborators
BioClin Therapeutics, Inc.
  More Information

Responsible Party: BioClin Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02401542     History of Changes
Other Study ID Numbers: B-701-U21
Study First Received: March 16, 2015
Last Updated: July 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BioClin Therapeutics, Inc.:
targeted therapy
second line therapy
combination therapy
Urothelial Cell Carcinoma
UCC
bladder cancer
B-701
FGFR3
invasive bladder cancer
Transitional Cell Carcinoma
TCC
Phase 2
monoclonal antibody
docetaxel
Phase 1

Additional relevant MeSH terms:
Carcinoma
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2017