Clinical trial · Interventional
Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors
A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors
NCT00739414CI-TRIAL-00048985completedPhase 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 characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists.
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| 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 (Panobinostat)
- interventionNames
- Drug: LBH589
Primary outcomes (1)
- measure
- To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors.
- timeFrame
- First cycle
Secondary outcomes (2)
- measure
- To characterize the pharmacokinetics (PK) of LBH589
- timeFrame
- First cycle
- measure
- To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists. 2. At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors 3. Age ≥20 years old 4. World Health Organization (WHO) Performance Status of ≤2 5. Patients must have the following laboratory values as defined in protocol 6. Life expectancy of ≥ 12 weeks 7. Written informed consent obtained Exclusion Criteria: 1. Patients with evidence of CNS tumor or metastasis 2. Patients with pleural effusion and/or ascites to be drained 3. Patients with any peripheral neuropathy ≥ CTCAE grade 2 4. Impaired cardiac function defined in protocol 5. Acute or chronic liver or renal disease 6. Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol 7. Patients who are currently receiving treatment with any of the medications which have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication 8. Patients who have received chemotherapy ≤4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
References
Publications (1)
- DERIVEDMorita S, Oizumi S, Minami H, Kitagawa K, Komatsu Y, Fujiwara Y, Inada M, Yuki S, Kiyota N, Mitsuma A, Sawaki M, Tanii H, Kimura J, Ando Y. Phase I dose-escalating study of panobinostat (LBH589) administered intravenously to Japanese patients with advanced solid tumors. Invest New Drugs. 2012 Oct;30(5):1950-7. doi: 10.1007/s10637-011-9751-0. Epub 2011 Oct 1. PMID 21964801