Back to resultsA Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589
Primary Purpose
Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LBH589
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies focused on measuring Advanced cancer, lymphoma, chronic hematological malignancies, adult
Eligibility Criteria
Inclusion criteria
- Histologically or cytologically confirmed cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2
- Normal renal and hepatic function
Exclusion criteria
- Patients with central nervous system (CNS) involvement or brain metastases
- Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
- Patients with congenital long QT syndrome or uncontrolled hypertension
- Patients with a myocardial infarction or unstable angina within 6 months
- Congestive heart failure
- Impairment of gastrointestinal (GI) function
- Use of any anti-cancer therapy
- Female patients who are pregnant or breast feeding
Other protocol inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LBH589
Arm Description
Outcomes
Primary Outcome Measures
Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589
oral dose of [14C] LBH589
Secondary Outcome Measures
Safety Efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00472368
Brief Title
A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589
Official Title
An Open-label, Single Center, Study to Determine the Absorption, Distribution, Metabolism, and Excretion (ADME) of LBH589 After a Single Oral Administration of 20 mg (14C) LBH589 in Advanced Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This single center study will help determine the absorption, metabolism, and excretion of LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom no standard therapy exists.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
Keywords
Advanced cancer, lymphoma, chronic hematological malignancies, adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LBH589
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LBH589
Other Intervention Name(s)
Panobinostat
Primary Outcome Measure Information:
Title
Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589
Description
oral dose of [14C] LBH589
Time Frame
during the first 8 days on study
Secondary Outcome Measure Information:
Title
Safety Efficacy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Histologically or cytologically confirmed cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies.
Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2
Normal renal and hepatic function
Exclusion criteria
Patients with central nervous system (CNS) involvement or brain metastases
Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
Patients with congenital long QT syndrome or uncontrolled hypertension
Patients with a myocardial infarction or unstable angina within 6 months
Congestive heart failure
Impairment of gastrointestinal (GI) function
Use of any anti-cancer therapy
Female patients who are pregnant or breast feeding
Other protocol inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589
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