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NCT01421004 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 166
- Enrollment target
NCT01421004: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01421004 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 166 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (177% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421004, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 166 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG TKI258
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT01421004 record still lists
NCT01421004 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (177% higher).
The record links to 0 conditions, and to 1 intervention - of which TKI258 is the first listed.
NCT01421004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01421004 about?
NCT01421004 is a clinical study titled "Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors". 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 consid...
What is the current status of trial NCT01421004?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 166 participants. The study started on 2011-12. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01421004?
The interventions under investigation include: TKI258 (DRUG).
Who is sponsoring clinical trial NCT01421004?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01421004's enrollment target sits among peer trials
166 330th of 2000 higher than 1,669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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