Status:
COMPLETED
A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Lymphoma
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy
- World Health Organization (WHO) performance status ≤ 2
- Patients who met protocol-specified hematologic and non-hematologic laboratory values
- Patients with adequate liver and renal function
- Exclusion criteria:
- Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
- Peripheral neuropathy ≥ CTCAE grade 2
- Unresolved diarrhea ≥ CTCAE grade 2
- Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589
- Female patients who were pregnant or breast feeding
- Patients who were unwilling to use an effective method of birth control
- Patients who took medications specified by the protocol as prohibited for administration in combination with LBH589
- Patients with another primary malignancy that required active intervention or were clinically significant
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2009
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00621244
Start Date
March 1 2003
End Date
December 3 2009
Last Update
January 5 2021
Active Locations (7)
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1
Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia
Augusta, Georgia, United States, 30912
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
MD Anderson Cancer Center/University of Texas
Houston, Texas, United States, 77030
4
Novartis Investigative Site
Parkville, Victoria, Australia, 3002