Clinical trial · Interventional
A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
A Phase IB, Study to Investigate the Effect of Ketoconazole, a CYP3A4 Inhibitor, on Oral LBH589 and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors.
NCT00503451CI-TRIAL-00048967completedPhase 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 open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in patients with advanced solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 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 on days 1, 5, 8, 9 and 10 of first cycle
- timeFrame
- 2 weeks
Secondary outcomes (1)
- measure
- Safety, tolerability and efficacy of oral LBH589 throughout the study
- timeFrame
- at least every 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma with progression on prior standard therapies. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Adequate kidney function and laboratory values Exclusion criteria: * Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago * Patients who had a heart attack or have unstable angina within past 6 months * Heart disease including congestive heart failure and uncontrolled high blood pressure * Liver disease, abnormal gastrointestinal (GI) function or ongoing diarrhea * Use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study * Female patients who are pregnant or breast feeding. Other protocol inclusion/exclusion criteria may apply.
References
Publications (1)
- DERIVEDHamberg P, Woo MM, Chen LC, Verweij J, Porro MG, Zhao L, Li W, van der Biessen D, Sharma S, Hengelage T, de Jonge M. Effect of ketoconazole-mediated CYP3A4 inhibition on clinical pharmacokinetics of panobinostat (LBH589), an orally active histone deacetylase inhibitor. Cancer Chemother Pharmacol. 2011 Sep;68(3):805-13. doi: 10.1007/s00280-011-1693-x. Epub 2011 Jun 26. PMID 21706316