A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
- Conditions
- Refractory Cutaneous T-Cell LynphomaMedDRA version: 14.1Level: PTClassification code 10051708Term: Lymphoma cutisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2006-000880-27-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 118
1. Written informed consent obtained prior to any screening procedures 2. Age >= 18 years old 3. Patients with biopsy-confirmed mycosis fungoides or Se'zary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study. 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. Patients must have the following laboratory values: ? Absolute neutrophil count (ANC) >= 1.5 x 10 9/L ? Hemoglobin (Hgb) >= 9 g/dl ? Platelets (plt) >= 100 x 10 9/L ? Serum potassium >= the lower limit of normal (LLN) ? Serum total calcium (corrected for serum albumin) or ionized calcium >= LLN ? Serum magnesium >= LLN ? Serum phosphorus >= LLN ? AST/SGOT and ALT/SGPT >= 2.5 x upper limit of normal (ULN) ? Serum bilirubin >= 1.5 x ULN ? Serum creatinine >= 1.5 x ULN or 24-hour clearance >= 50 ml/min ? TSH and free T4 within normal limit (WNL) (patients may be on thyroid hormone replacement) ? Albumin > 3g/dL Potassium, calcium, magnesium and phosphorus supplements may be given to correct values that are < LLN, but there must be documented as corrected prior to patients enrolling on the study. 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: 0
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
1. Prior treatment with an HDAC inhibitor. 2. Patients with any history of visceral disease including CNS involvement (i.e. a history of stage IVB CTCL even the IVB disease has been down-staged at the time of study enrollment). Note: Patients who have SS with bone marrow involvement are eligible. 3. Impaired cardiac function, including any one of the following ? Screening ECG with a QTc > 450 msec confirmed by central laboratory prior to enrollment to the study ? Patients with congenital long QT syndrome ? History of sustained ventricular tachycardia (Patients with a history of atrial arrhythmia are eligible but should be discussed with the Sponsor prior to enrollment) ? Any history of ventricular fibrillation or torsade de pointes ? Bradycardia defined as HR < 50 beats per minute. Patients with pacemakers are eligible if HR ≥ 50 bpm. ? Patients with a myocardial infarction or unstable angina within 6 months of study entry ? Congestive heart failure (NY Heart Association class III or IV) ? Right bundle branch block and left anterior hemiblock (bifasicular block) 4. Uncontrolled hypertension 5. Concomitant use of any anti-cancer therapy or radiation therapy. Topical steroid use is permitted. 6. Concomitant use of drugs with a risk of causing torsades de pointes (See Post-text Supplement 1) 7. Concomitant use of CYP3A4/5 inhibitors (see Post-text supplement 1) 8. Patients with unresolved diarrhea > CTCAE grade 1 9. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589 10. Other concurrent severe and/or uncontrolled medical conditions 11. 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 12. Less than 3 months since prior electron beam therapy 13. Patients who have received wide field radiotherapy < 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy 14. 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 of the first administration of oral LBH589 15. Male patients whose sexual partners are WOCBP not using effective birth control 16. Patients with a history of another primary malignancy within 5 years other than curatively treated CIS of the cervix, completely excised melanoma-in-situ, or basal or squamous cell carcinoma of the skin 17. Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method