Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278978
Recruitment Status : Unknown
Verified May 2015 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 30, 2014
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: BIBF1120 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016


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 Name: Nintedanib

Experimental: FGFR3 overexpressed
BIBF 1120 in patients with advanced FGFR3 overexpressed
Drug: BIBF1120
BIBF1120 200 mg two times per day orally
Other Name: 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 Name: Nintedanib




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278978


Locations
Layout table for location information
Taiwan
Chia-Chi Lin
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chia-Chi Lin, Ph.D National Taiwan University Hospital

Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02278978    
Other Study ID Numbers: 201306022MIPB
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by National Taiwan University Hospital:
urothelial carcinoma
BIBF1120
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action