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

National Taiwan University

Status and phase: Unknown; Phase 2

Conditions: Urothelial Carcinoma

Treatments: Drug: BIBF1120

Study type: Interventional

Funder types: Other

Identifiers

NCT02278978

201306022MIPB

Details and patient eligibility

About

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.

Enrollment: 129 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

129 participants in 3 patient groups

FGFR3 mutated

Experimental group

Description:

BIBF 1120 in patients with advanced FGFR3 mutated

Treatment:

Drug: BIBF1120

FGFR3 overexpressed

Experimental group

Description:

BIBF 1120 in patients with advanced FGFR3 overexpressed

Treatment:

Drug: BIBF1120

FGFR3 wild type

Experimental group

Description:

BIBF 1120 in patients with advanced FGFR3 wild type

Treatment:

Drug: BIBF1120