Clinical trial · Interventional
A Phase I Study to Determine the Effect of Food on Brivanib (BMS-582664)
Phase I Study to Determine the Effect of a High Fat Meal on the Pharmacokinetics of BMS-540215, the Active Metabolite of Brivanib Alaninate in Subjects With Advanced or Metastatic Solid Tumors
NCT00437437CI-TRIAL-00010912completedPhase 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)
The purpose of this trial is to determine the effect of food versus a fasted state on single-dose pharmacokinetics of BMS-540215, the active metabolite of Brivanib alaninate
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brivanib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Brivanib
Primary outcomes (1)
- measure
- To determine the effect on pharmacokinetics of BMS-540215, the active metabolite of brivanib alaninate, when administered following a high fat meal versus administration in a fasted state
- timeFrame
- throughout the study
Secondary outcomes (1)
- measure
- To assess safety and tolerability of Brivanib alaninate when administered in a fasted state, or following a high fat meal
- timeFrame
- throughout the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. Inclusion Criteria: * Histologic/cytologic diagnosis of advanced or metastatic solid tumors * ECOG 0-2 * 4/6 weeks since prior therapy Exclusion Criteria: * Brain metastases * Second primary malignancy * Thromboembolic disease requiring full anticoagulation within 6 months * Inability to swallow or absorb oral therapy
References
Publications (0)
Data not yet available
No reference posted for this study.