Phase II study of Oral Panobinostat in Adult Patients with Relapsed/Refractory Classical Hodgkin's Lymphoma

Phase 1

Conditions: relapsed/refractory classical Hodgkin's lymphoma
MedDRA version: 14.1 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2008-003016-35-GB

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 129

Inclusion Criteria

1. Patient age is = 18 years
2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of = 2
3. Patient has a history of classical HL (i.e. Nodular sclerosing, Mixedcellularity, Lymphocyte-rich, Lymphocyte depleted)
4. Patient has progressive disease after receiving high dose chemotherapy with AHSCT.
Note: If last therapy was more than = 18 months ago, then a biopsy
should be performed to confirm diagnosis.
Note: Patient should have received <= 5 prior systemic treatment regimens (see PTS 2)
5. Patient has at least one site of measurable nodal disease at baseline = 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. (MRI is allowed only if CT scan can not be performed).
Note: Patients with bone marrow involvement are eligible, but this
criterion alone should not be used for disease measurement.
6. Patient has the following laboratory values (labs may be repeated, if needed, to obtain acceptable values before screen fail):
• Absolute neutrophil count (ANC) = 1.5 x 10exp9/L [SI units 1.5 x10exp9/L]
• Platelet count = 75 x 10exp9/L
• Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution
Note: Potassium, calcium, magnesium, sodium, and/or phosphorus supplements may be given to correct values that are • Serum creatinine = 1.5 x ULN
• Serum bilirubin = 1.5 x ULN (or = 3.0 x ULN, if patient has Gilbert syndrome)
• AST/SGOT and/or ALT/SGPT = 2.5 x upper limit of normal (ULN) or = 5.0 x ULN if the transaminase elevation is due to disease involvement
7. Clinically euthyroid
Note: Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
8. Written informed consent was obtained from the patient prior to any study-specific screening procedures
9. Patient has the ability to swallow capsules or tablets
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. Patient has a history of prior treatment with a DAC inhibitor including panobinostat
2. Patient will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat treatment
3. Patient has been treated with monoclonal antibody therapy (e.g.,rituximab or anti CD-30 antibody, etc.) within 4 weeks of start of study treatment
4. Patient has received chemotherapy or any investigational drug or undergone major surgery = 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to = grade 1
5. Patient has been treated with > 5 prior systemic lines of treatment (see Post-text supplement 2 for definitions and examples)
6. Patient has received prior radiation therapy = 4 weeks or limited field radiotherapy = 2 weeks prior to start of study treatment or whose side effects of such therapy have not resolved to = grade 1
7. Patient is using any anti-cancer therapy concomitantly
8. Patient treated with allogeneic hematopoietic stem cell transplant who is currently on or has received immunosuppressive therapy within 90 days prior to start of screening and/or have = Grade 2 graft versus host disease (GvHD).
9. Patient has a history of another primary malignancy = 3 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
10. Patient has a history of CNS involvement with lymphoma
11. Patient has impaired cardiac function including any of the following:
• Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute), QTcF > 450 msec on
screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular block)
• Presence of unstable atrial fibrillation (ventricular heart rate >100bpm). Patients with stable atrial fibrillation are allowed in the study provided they do not meet the other cardiac exclusion criteria
• Previous history angina pectoris or acute MI within 6 months
• Congestive heart failure (New York Heart Association functional classification III-IV)
12. Patient has any other clinically significant heart disease (e.g.,uncontrolled hypertension)
13. Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
14. Patient has unresolved diarrhea = grade 2
15. Patient has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) that could cause unacceptable safety risks or compromise compliance
with the protocol
16. Patient has a known history of HIV seropositivity (screening HIV testing is not required)
17. Patient is using medications that have a re

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

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