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A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Phase
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Protocol IDs
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Phase II, Phase I
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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CLBH589B2102
NCT00621244
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Trial Description
Summary This study will evaluate safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies Eligibility Criteria Inclusion criteria - Adult patients (≥18 years old) with advanced hematological malignancies who have relapsed after or are refractory to standard therapy, or for which no standard therapy exists; or, are considered inappropriate candidates for standard therapy
- World Health Organization (WHO) performance status ≤ 2
- Patients must meet protocol-specified hematologic and non-hematologic laboratory values
- Patients must have 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 may compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that may significantly alter aborption of LBH589
- Female patients who are pregnant or breast feeding
- Patients not willing to use an effective method of birth control
- Patients taking medications specified by the protocol as prohibited for administration in combination with LBH589
- Patients with another primary malignancy that currently requires active intervention or is currently clinically significant
Other protocol-defined inclusion/exclusion criteria may apply
Trial Contact Information
Trial Lead Organizations/Sponsors Novartis Pharmaceuticals Corporation | Novartis | | Study Chair |
| Novartis US | | Ph: 862 778 8300 |
| Novartis Basel | | Ph: 41 61 324 1111 |
Trial Sites
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| U.S.A. |
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| Georgia |
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Augusta |
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| | | | | | | | Medical College of Georgia Cancer Center |
| | | Kapil Bhalla, M.D. |
Ph: 706-721-0463 |
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| Massachusetts |
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Boston |
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| | | | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
| | | Daniel DeAngelo, M.D. |
Ph: 617-632-2645 |
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Email:
ddeangelo@partners.org |
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| Australia |
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Melbourne |
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| Germany |
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Frankfurt |
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Mainz |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00621244
Information obtained from ClinicalTrials.gov on July 15, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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