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

Urothelial Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02278978
• Other study ID #: 201306022MIPB
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 28, 2014
• Last updated: May 10, 2015
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2015
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• BIBF1120
BIBF1120 200 mg two times per day orally

Locations

Country	Name	City	State
Taiwan	Chia-Chi Lin	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate assessed by RECEST version 1.1	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	No