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This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate that those 2 formulations are considered to be the same for all intents and purposes by making sure they are acting on the body with the same strength and are absorbed in similar amounts by the body. During the bioequivalence phase, patients will take orally at a daily dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days on/2days off dosing schedule, after which time, patients will switch to the alternate formulation for one additional week. After the bioequivalence phase, all patients may continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 500 mg FMI capsule + 250 mg FMI tablet | Experimental | BE phase sequence 1= 3 weeks on FMI capsule then 1 week on FMI tablet |
|
| 500 mg TKI258 FMI capsule +250 mg FMI tablet | Experimental | BE phase sequence 2= 3 weeks on FMI tablet then 1 week on FMI capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKI258 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Pharmacokinetics of TKI258, FMI capsule (supplied in 100 mg strength) and FMI tablet (supplied in 250 mg strength), in patients with advanced solid tumors, excluding breast cancer based on PK parameters AUClast and Cmax | 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events in patients treated with TKI258 on a 5 days on/2 days off dosing schedule in patients with advanced solid tumors, excluding breast cancer | up to 30 days after the last dose of study drug | |
| Preliminary evidence of anti-tumor activity based on RECIST criteria of TKI258 in patients with advanced solid tumors, excluding breast cancer |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartitis Pharmaceuticals | Novartitis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center SC-2 | Duarte | California | 91010-3000 | United States | ||
| University of California at Los Angeles UCLA LeConte Location |
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| Label | URL |
|---|---|
| Results for CTKI258A2128 can be found on the Novartis Clinical Trial Results Website | View source |
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| Every 8 weeks until progression of disease |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California San Francisco UCSF (SC) | San Francisco | California | 94101 | United States |
| Florida Cancer Specialists Sarasota Office | Fort Myers | Florida | 33901 | United States |
| Rush University Medical Center Rush 3 | Chicago | Illinois | 60612 | United States |
| Washington University School of Medicine SC | St Louis | Missouri | 63110 | United States |
| Montefiore Medical Center Montefiore Medical Center (SC) | The Bronx | New York | 10467 | United States |
| University of Oklahoma Health Sciences Center OUHSC - SC | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232-1305 | United States |
| Sarah Cannon Research Institute Sarah Cannon Research (SC) | Nashville | Tennessee | 37203 | United States |
| Sammons Cancer Center - Texas Oncology SC-2 | Dallas | Texas | 78246 | United States |
| Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) | San Antonio | Texas | 78229 | United States |
| University of Utah / Huntsman Cancer Institute Huntsman | Salt Lake City | Utah | 84112 | United States |
| University of Wisconsin Univ Wisc | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C500007 | 4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one |
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