A Phase II Study Of Oral LBH589 In Adult Patients With Refractory Cutaneous T-Cell Lymphoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 118

Inclusion Criteria

1. Written informed consent obtained prior to any screening procedures
2. Age = 18 years old
3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA, photophoresis, chemotherapy such as methotrexate, and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
7. Patients must have specific laboratory values (see protocol)
8. Baseline MUGA or ECHO must demonstrate LVEF = the lower limit of the institutional normal
9. ECOG Performance Status = 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior treatment with an HDAC inhibitor.
2. Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note; Patients with SS who have bone marrow involvement are eligible.
3. Impaired cardiac function (details see protocol)
4. Concomitant use of drugs with a risk of causing torsades des pointes
5. Patients who have received chemotherapy or any investigational drug or undergone major surgery <4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
6. Less than 3 months since prior electron beam therapy
7. Female patients who are pregnant or breast feeding, or patients of reproductive potential not using an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to administration of oral LBH589
8. Male patients whose sexual partners are WOCBP not using effective birth control

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the response rate of patients with refractory CTCL treated with oral LBH589 as determined by using a modified Severity-Weighted Assessment Tool (mSWAT).;Secondary Objective: To determine in patients with refractory CTCL, the:<br>1. Response rate using the Physicians Global Assessment of Clinical Condition (PGA)<br>2. Responses in index lesions by lesion measurements with photographic supporting documentation<br>3. Improvement in CTCL-related symptoms and patient-reported outcomes<br>4. Duration of response<br>5. Time to response<br>6. Progression-free survival<br>7. Safety and tolerability<br>8. Pharmacokinetic (PK) profile of LBH589<br>9. Potential biological factors that might correlate with efficacy and response.<br>;Primary end point(s): - Efficacy<br>- Response rate<br><br><br>

Secondary Outcome Measures

Name	Time	Method

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A Phase II Study Of Oral LBH589 In Adult Patients With Multiple Myeloma Who Have Received At Least Two Prior Lines Of Therapy And Whose Disease Is Refractory To The Most Recent Line Of Therapy

ovartis Pharma Services AG

Updated 4/24/2012