Urothelial Cancer Clinical Trial
Official title:
A Phase II Multi-center, Non-randomized, Open Label Study of TKI258 in FGFR3 Mutated and FGFR3 Wild Type Advanced Urothelial Carcinoma
| Verified date | August 2020 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | April 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novartis Investigative Site | Vienna | |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Canada | Novartis Investigative Site | Victoria | British Columbia |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Ulm | |
| Italy | Novartis Investigative Site | Roma | RM |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Barcelona | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Taiwan | Novartis Investigative Site | Tainan 704 | Taiwan ROC |
| Taiwan | Novartis Investigative Site | Taipei | |
| United Kingdom | Novartis Investigative Site | Leeds | West Yorkshire |
| United Kingdom | Novartis Investigative Site | Southampton | |
| United States | Dana Farber Cancer Institute Dana 1230 | Boston | Massachusetts |
| United States | University Chicago Hospital CTKI258A2201 | Chicago | Illinois |
| United States | Duke University Medical Center Dept.ofDukeUniversityMedCtr(2) | Durham | North Carolina |
| United States | University of California San Diego - Moores Cancer Center UCSD | La Jolla | California |
| United States | Nevada Cancer Institute Nevada Cancer Institute | Las Vegas | Nevada |
| United States | USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3 | Los Angeles | California |
| United States | The West Clinic | Memphis | Tennessee |
| United States | Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2) | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Austria, Canada, Germany, Italy, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall response rate | 4 months | ||
| Secondary | Disease control rate | 4 Months | ||
| Secondary | Progression free survival | 4 Months | ||
| Secondary | overall survival | 4 Months |
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