A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00621244
First received: February 12, 2008
Last updated: May 1, 2012
Last verified: May 2012
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Purpose
This study will evaluate safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Leukemia Multiple Myeloma |
Drug: LBH589 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Establish the maximum tolerated dose and dose-limiting toxicity for two different dosing schedules (MWF weekly or MWF every other week), [ Time Frame: 2.7 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Characterize the safety and tolerability of LBH589 throughout study and up to 28 days after last dose of study drug [ Time Frame: 3.4 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 308 |
| Study Start Date: | March 2006 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: LBH589 |
| Experimental: 2 | Drug: LBH589 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621244
Locations
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Australia | |
| Novartis Investigative Site | |
| Melbourne, Australia | |
| Germany | |
| Novartis Investigative Site | |
| Frankfurt, Germany | |
| Novartis Investigative Site | |
| Mainz, Germany | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00621244 History of Changes |
| Other Study ID Numbers: | CLBH589B2102 |
| Study First Received: | February 12, 2008 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Australia: Therapeutic Goods Administration |
Keywords provided by Novartis:
|
HDAC inhibitor Oral LBH589 |
Lymphoma Leukemia Multiple myeloma |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Hematologic Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Neoplasms by Site |
ClinicalTrials.gov processed this record on May 22, 2013