Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors

Conditions
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Cancer, Advanced Solid Tumor

Intervention / Treatment
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* Drug: LBH589


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists. At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors Age ≥20 years old World Health Organization (WHO) Performance Status of ≤2 Patients must have the following laboratory values as defined in protocol Life expectancy of ≥ 12 weeks Written informed consent obtained Exclusion Criteria: Patients with evidence of CNS tumor or metastasis Patients with pleural effusion and/or ascites to be drained Patients with any peripheral neuropathy ≥ CTCAE grade 2 Impaired cardiac function defined in protocol Acute or chronic liver or renal disease Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol 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 Patients who have received chemotherapy ≤4 weeks prior to starting study drug or who have not recovered from side effects of such therapy

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBH589 (Panobinostat)<br> | Drug: LBH589<br>* 10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle<br>* Other names: Panobinostat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors. |  | First cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics (PK) of LBH589 |  | First cycle | 
| To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors |  | Every 2 cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Histone Deacetylases, HDAC inhibitor, LBH589, Advanced solid tumor, Adult