Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT01421004. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I, Open-label, Multi-center, Randomized, Crossover Study to Assess the Bioequivalence of 2 Formulations of TKI258, FMI Capsule and FMI Tablet, in Patients With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01421004
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 166 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2011
- Primary completion
- Jun 30, 2014
- Completion
- Jun 30, 2014
- Last update posted
- Dec 20, 2020
2011 – 2014
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center SC-2 | Duarte | California | 91010-3000 | — |
| University of California at Los Angeles UCLA LeConte Location | Los Angeles | California | 90095 | — |
| University of California San Francisco UCSF (SC) | San Francisco | California | 94101 | — |
| Florida Cancer Specialists Sarasota Office | Fort Myers | Florida | 33901 | — |
| Rush University Medical Center Rush 3 | Chicago | Illinois | 60612 | — |
| Washington University School of Medicine SC | St Louis | Missouri | 63110 | — |
| Montefiore Medical Center Montefiore Medical Center (SC) | The Bronx | New York | 10467 | — |
| University of Oklahoma Health Sciences Center OUHSC - SC | Oklahoma City | Oklahoma | 73104 | — |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232-1305 | — |
| Sarah Cannon Research Institute Sarah Cannon Research (SC) | Nashville | Tennessee | 37203 | — |
| Sammons Cancer Center - Texas Oncology SC-2 | Dallas | Texas | 78246 | — |
| Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) | San Antonio | Texas | 78229 | — |
| University of Utah / Huntsman Cancer Institute Huntsman | Salt Lake City | Utah | 84112 | — |
| University of Wisconsin Univ Wisc | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01421004, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 20, 2020 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01421004 live on ClinicalTrials.gov.