Clinical trial · Interventional
Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors
A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258 (CSF Capsule vs. FMI Tablet), and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors
NCT01155713CI-TRIAL-00049040completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TKI258 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 - TKI258 - bioavailability
- interventionNames
- Drug: TKI258
- type
- EXPERIMENTAL
- label
- TKI258 - food effect
- interventionNames
- Drug: TKI258
Primary outcomes (2)
- measure
- Determine the relative bioavailability of the final market image form of TKI258 (monohydrate tablets) as compared to the clinical service form of TKI258 (anhydrate capsules)
- timeFrame
- relative bioavailability (9 days)
- measure
- Determine the effect of food on the bioavailability of TKI258
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists * World Health Organization (WHO) performance status ≤ 2 * Patient must meet protocol-specified laboratory values Exclusion Criteria: * Patients with brain cancer * Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study * Patients who have not recovered from previous anti-cancer therapies * Female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.