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
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
Both
Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
Trial Information
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
Inclusion 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589
Outcome Description:
oral dose of [14C] LBH589
Outcome Time Frame:
during the first 8 days on study
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CLBH589B2108
NCT ID:
NCT00472368
Start Date:
May 2007
Completion Date:
Related Keywords:
- Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
- Advanced cancer
- lymphoma
- chronic hematological malignancies
- adult
- Neoplasms
- Lymphoma
- Hematologic Neoplasms
Name | Location |
|---|---|
| Novartis Investigative Site | Buffalo, New York 14263 |
