BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma

May 10, 2015 updated by: National Taiwan University Hospital

A Phase II Trial of BIBF1120 in Patients With Advanced FGFR3 Mutated, FGFR3 Overexpressed, or FGFR3 Wild Type Urothelial Carcinoma of Urinary Bladder, Urethra, Ureter, and Renal Pelvis and Who Have Failed Platinum-based Chemotherapy

BIBF1120 in patients with advanced FGFR3 mutated, FGFR3 overexpressed, or FGFR3 wild type urothelial carcinoma of urinary bladder, urethra, ureter, and renal pelvis and who have failed platinum-based chemotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

129

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Chia-Chi Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • KPS 60%
  • Histological confirmation of urothelial carcinoma , with metastatic disease
  • Measurable disease
  • Previously treated with platinum-based chemotherapy administered

Exclusion Criteria:

  • Radiographic evidence of cavitary or necrotic tumours
  • Active brain metastasis.Leptomeningeal metastasis
  • Chemotherapy, radiotherapy, targeted therapy with monoclonal antibodies or small tyrosine kinase inhibitors
  • Grade 1 treatment-related toxicity from previous chemotherapy, radiotherapy, or targeted therapy
  • Prior treatment with BIBF 1120 or other VEGFR inhibitors
  • Significant cardiovascular diseases:
  • Pericardial effusion
  • Significant bleeding or thrombosis
  • Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
  • Major injuries within the past 10 days with incomplete wound healing and/or planned surgery during the on-treatment study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FGFR3 mutated
BIBF 1120 in patients with advanced FGFR3 mutated
Drug: BIBF1120
BIBF1120 200 mg two times per day orally
Other Names:
  • Nintedanib
Experimental: FGFR3 overexpressed
BIBF 1120 in patients with advanced FGFR3 overexpressed
Drug: BIBF1120
BIBF1120 200 mg two times per day orally
Other Names:
  • Nintedanib
Experimental: FGFR3 wild type
BIBF 1120 in patients with advanced FGFR3 wild type
Drug: BIBF1120
BIBF1120 200 mg two times per day orally
Other Names:
  • Nintedanib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate assessed by RECEST version 1.1
Time Frame: 2 months
To define the response rate of BIBF1120 in patients with advanced FGFR3-mutated,overexpressed,wild type UC and who have failed platinum-based chemotherapy.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Chia-Chi Lin, Ph.D, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 10, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201306022MIPB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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