Clinical trial · Interventional
A Study to Investigate the Effect of Food on Oral LBH589 Absorption in Patients With Advanced Solid Tumors
A Phase Ib Open-label, Multicenter Cross-over Study to Investigate the Effect of Food on the Rate and Extent of Oral LBH589 Absorption in Patients With Advanced Solid Tumors
NCT00570284CI-TRIAL-00048950completedPhase 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 primary purpose of this study is to evaluate the effect of food on oral LBH589 in adult patients with advanced solid tumors. This study will also evaluate the safety and efficacy of LBH589 in adult patients with advanced solid tumors
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LBH589 | Drug | Panobinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBH589
- interventionNames
- Drug: LBH589
Primary outcomes (1)
- measure
- Levels of LBH589 in the blood
- timeFrame
- every week for the first 3 weeks
Secondary outcomes (1)
- measure
- Efficacy, Safety and tolerability
- timeFrame
- throughout study to 28 days after last treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists * Age ≥ 18 years old * Patients must have adequate laboratory values * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Ability to swallow capsules or tablets Exclusion criteria: * Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months. * Patients with a second primary malignancy that is currently clinically significant or requiring active intervention * Impaired heart function or clinically significant heart disease * Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589 * Ongoing diarrhea * Liver or renal disease with impaired hepatic or renal functions * Concomitant use of any anti-cancer therapy or certain drugs * Female patients who are pregnant or breast feeding * Patients 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.