NCT02278978

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
129

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

October 28, 2014

Last Update Submit

May 10, 2015

Conditions

Urothelial Carcinoma

Keywords

urothelial carcinomaBIBF1120

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

FGFR3 mutated

EXPERIMENTAL

BIBF 1120 in patients with advanced FGFR3 mutated

Drug: BIBF1120

FGFR3 overexpressed

EXPERIMENTAL

BIBF 1120 in patients with advanced FGFR3 overexpressed

Drug: BIBF1120

FGFR3 wild type

EXPERIMENTAL

BIBF 1120 in patients with advanced FGFR3 wild type

Drug: BIBF1120

Interventions

BIBF1120DRUG

BIBF1120 200 mg two times per day orally

Also known as: Nintedanib
FGFR3 mutatedFGFR3 overexpressedFGFR3 wild type

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chia-Chi Lin

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

nintedanib

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Chia-Chi Lin, Ph.D

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2014

First Posted

October 30, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

TW(1)