Phase II Study of TKI258 in Advanced Urothelial Carcinoma

Novartis

Status and phase

Completed

Phase 2

Conditions

Urothelial Cancer

Treatments

Drug: TKI258

Study type

Interventional

Funder types

Industry

Identifiers

2008-005870-11 (EudraCT Number)

EudraCT 2008-005870-11

CTKI258A2201

Details and patient eligibility

About

This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with transitional cell cancer of the bladder, urethra, ureter, or renal pelvis
Patients who have archival tumor tissue available for FGFR3 mutational status screening
Patients with progressive disease
Patients with measurable disease by RECIST
Patients previously treated with at least 1 but not more than 3 systemic cytotoxic regimens with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane administered in the perioperative or advanced setting
Age ≥ 18 years
WHO Performance Status ≤ 2
Patients willing and able to take oral medication, follow scheduled visits, treatment plan and laboratory tests
Patients with signed and witnessed informed consent form
Patients with adequate organ function

Exclusion criteria

Patients with brain cancer
Patients with other cancers except for certain skin, cervical & prostate cancers
Patients who have not recovered from previous cancer treatment
Patients who have severe and/or uncontrolled medical conditions which could affect participation in the study

Other protocol-defined inclusion/exclusion criteria may apply