Clinical trial · Interventional
LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
A Phase I Dose-escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
NCT00412997CI-TRIAL-00008541completedPhase 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 phase I study will evaluate the safety, efficacy and pharmacokinetics of LBH589B in adult patients with advanced solid tumors or Cutaneous T-cell lymphoma
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 |
|---|---|---|---|
| Cutaneous T-Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Tumors | 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
- To determine the maximum-tolerated dose of LBH589
- timeFrame
- 1st cycle
Secondary outcomes (3)
- measure
- Safety and tolerability assessed by AEs, SAEs and laboratory values.
- timeFrame
- Every 2 weeks
- measure
- To characterize the pharmacokinetic (PK) profile of LBH589
- timeFrame
- every 3 cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with either a) histologically-confirmed, advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists, or b) cytopathologically confirmed cutaneous T-cell lymphoma (CTCL) whose disease has progressed despite standard therapy or for whom no standard therapy exists. Inclusion is irrespective of stage of disease or extent of prior therapy. * World Health Organization (WHO) Performance Status of ≤ 2 * Patients must have the adequate laboratory values Exclusion Criteria: * Patients with a history of primary CNS tumors * Patients with any history of brain metastases * Patients with any peripheral neuropathy ≥ CTCAE grade 2 * Patients with unresolved diarrhea ≥ CTCAE grade 2 * Impairment of cardiac function * Impairment of gastrointestinal (GI) function or GI disease * Liver or renal disease Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.