Safety and Efficacy of TKI258 in Adult Patients With Advanced Urothelial Cancer

This study is not yet open for participant recruitment.

Verified by Novartis, November 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00790426

Purpose

This study will assess the safety and efficacy of TKI258 in patients with advanced urothelial cancer

Condition	Intervention	Phase
Urothelial Cancer	Drug: TKI258	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Chir 258

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment
Official Title:	A Phase II Multi-Center, Open Label Study of TKI258 Administered Orally in Adult Patients With Advanced Urothelial Carcinoma (UC)

Further study details as provided by Novartis:

Primary Outcome Measures:

Progression free survival [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Estimated Enrollment:	150
Study Start Date:	February 2009
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: TKI258

Eligibility

Criteria

Inclusion Criteria:

Patients with MSKCC histological confirmation of transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
Archival tissue available
Patients with progressive disease

Exclusion Criteria:

All previous treatment (including surgery and radiotherapy) completed at least 4 weeks prior to study entry
Treatment with investigational drugs within 30 days before the start of the trial.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790426

Contacts

Contact: Novartis Pharmaceuticals

+1 800 340 6843

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	TKI258A2201, EudraCT 2008-005870-11
Study First Received:	November 10, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00790426
Health Authority:	United States: Food and Drug Administration; Austria: Federal Office for Safety in Health Care; Canada: Health Canada; Germany: BfArM; Italy: The Italian Medicines Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Spanish Agency of Medicines; Taiwan: Center of Drug Evaluation

Keywords provided by Novartis:

Advanced urothelial cancer

Study placed in the following topic categories:

Carcinoma, Transitional Cell
Transitional cell carcinoma
Carcinoma

ClinicalTrials.gov processed this record on January 16, 2009