Study of LBH589, A Deacetylase Inhibitor in Patients With Recurrent or Refractory Hodgkin or Non-Hodgkin's Lymphoma

NCT01032148 | Terminated Phase 1 DMC

• 1 other identifier: RPCI I 147408
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out the effects of a drug called LBH589 when given to people with recurrent or refractory Hodgkin or Non-Hodgkin's lymphoma. The safety of this drug will also be studied. The participants' physical state, changes in the size of the tumor, or state of Hodgkin or non-Hodgkin's Lymphoma, and laboratory findings taken while on-study will help the researchers decide if LBH589 is safe and effective.

Conditions

Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma

Keywords

Recurrent; Refractory

Outcome Measures

Primary Outcomes (1)

• Determine maximum tolerated dose (MTD) of LBH589

  2 years

Secondary Outcomes (2)

• Determine toxicity profile in study population

  28 days after Cycle 2 Day 1

• Determine anti-lymphoma activity of LBH589 in (non-CTCL) Hodgkin's and non-Hodgkin's lymphoma patients

  2 Years

Study Arms (1)

LBH589

EXPERIMENTAL

LBH589 administered orally as once daily dose of 20 mg po q M, W, F on a q 28 day cycle, escalating to a maximum dase of 60 mg

Drug: LBH589

Interventions

LBH589 DRUG

LBH589 will be administered orally as once daily dose of 20 mg po q M, W, F on a q28 day cycle.

LBH589

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients age ≥ 18 years old with relapsed/refractory Hodgkin lymphoma or NHL patients who have relapsed or are refractory after receiving a minimum of two prior therapies
• Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
• Laboratory requirements:
• ANC ≥ 1.5 x 10(9th)/L, unless due to bone marrow involvement with lymphoma
• Hemoglobin ≥ 9 g/dl without packed red blood cell dependency, unless due to bone marrow involvement with lymphoma
• Platelets ≥ 100 x 10(9th)/L, unless due to bone marrow involvement with lymphoma
• Serum creatinine ≤ 1.5 x Upper limit of Normal, or calculated Creatinine Clearance ≥ 50 mL/min
• AST and ALT ≤ 2.5 x Upper limit of Normal, unless due to liver involvement with lymphoma
• Serum bilirubin ≤ 1.5 x Upper limit of Normal
• Albumin \> 3.0 g/dl
• Serum potassium ≥ Lower limit of Normal
• Total serum calcium \[corrected for serum albumin\] or ionized calcium ≥ Lower limits of normal
• Serum magnesium ≥ Lower limit of Normal
• Serum phosphorus ≥ Lower limit of Normal
• TSH ≥ LLN and free T4 within normal limits. Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.

You may not qualify if:

• Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
• Patients who will need valproic acid for any medication during the study or within 5 days prior to first LBH589 treatment
• Peripheral neuropathy ≥ CTCAE grade 1
• Impaired cardiac function or clinically significant cardiac diseases, including any one of the following:
• Patients with congenital QT syndrome
• History or presence of sustained ventricular tachyarrhythmia.
• Any history of ventricular fibrillation or torsade de pointes
• Bradycardia defined as Heart Rate \< 50 bpm. Patients with pacemakers are eligible if Heart Rate ≥ 50 bpm
• Screening EKG with a QTc.450msec
• Right Bundle branch block + left anterior hemiblock (bifascicular block)
• Patients with myocardial infarction or unstable angina ≤ 6 months prior to starting study drug
• other clinically significant heart disease (e.g. CHF NY Heart Association class III or IV, uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen)
• Impairment of GI function or GI disease that may significantly alter the absorption of LBH589
• Patients with Diarrhea \> CTCAE grade 1
• Other concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values that could cause unaccepted safety risks or compromise compliance with the protocol

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Novartis: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin; Recurrence

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Francisco Hernandez, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

US (1)