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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
Not Enrolling
Both
Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies

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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 SiteBuffalo, New York  14263