Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies Clinical Trial
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
| NCT number | NCT00472368 |
| Other study ID # | CLBH589B2108 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | May 10, 2007 |
| Last updated | April 27, 2012 |
| Start date | May 2007 |
| Verified date | April 2012 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 4 |
| Est. completion date | |
| Est. primary completion date | June 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Novartis Investigative Site | Buffalo | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | during the first 8 days on study | No |
| Secondary | Safety Efficacy |