Phase II Study of TKI258 in Advanced Urothelial Carcinoma

Phase 2

Completed

• Conditions: Urothelial Cancer
• Interventions: Drug: TKI258

• Registration Number: NCT00790426
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-13
• Study Start: 2010-03
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2020-08
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-28
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FGFR3 wild type	TKI258	-
FGFR3 mutant	TKI258	-

Primary Outcome Measures

Name	Time	Method
Overall response rate	4 months

Secondary Outcome Measures

Name	Time	Method
Disease control rate	4 Months
Progression free survival	4 Months
overall survival	4 Months

Trial Locations

Locations (9)

University of California San Diego - Moores Cancer Center UCSD; 🇺🇸 La Jolla, California, United States

USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3; 🇺🇸 Los Angeles, California, United States

University Chicago Hospital CTKI258A2201; 🇺🇸 Chicago, Illinois, United States

Dana Farber Cancer Institute Dana 1230; 🇺🇸 Boston, Massachusetts, United States

Nevada Cancer Institute Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States

Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2); 🇺🇸 New York, New York, United States

Duke University Medical Center Dept.ofDukeUniversityMedCtr(2); 🇺🇸 Durham, North Carolina, United States

The West Clinic; 🇺🇸 Memphis, Tennessee, United States

Novartis Investigative Site; 🇬🇧 Southampton, United Kingdom