Status:
COMPLETED
A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 therap...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00472368
Start Date
May 1 2007
Last Update
May 1 2012
Active Locations (1)
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1
Novartis Investigative Site
Buffalo, New York, United States, 14263