Back to resultsLBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
Primary Purpose
Tumors, Cutaneous T-Cell Lymphoma
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
LBH589
Sponsored by
About this trial
This is an interventional treatment trial for Tumors focused on measuring advanced solid tumor, Cutaneous T-cell lymphoma, Phase I, HDAC inhibitor, Adult patients
Eligibility Criteria
Inclusion Criteria:
- Patients with either a) histologically-confirmed, advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists, or b) cytopathologically confirmed cutaneous T-cell lymphoma (CTCL) whose disease has progressed despite standard therapy or for whom no standard therapy exists. Inclusion is irrespective of stage of disease or extent of prior therapy.
- World Health Organization (WHO) Performance Status of ≤ 2
- Patients must have the adequate laboratory values
Exclusion Criteria:
- Patients with a history of primary CNS tumors
- Patients with any history of brain metastases
- Patients with any peripheral neuropathy ≥ CTCAE grade 2
- Patients with unresolved diarrhea ≥ CTCAE grade 2
- Impairment of cardiac function
- Impairment of gastrointestinal (GI) function or GI disease
- Liver or renal disease
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LBH589
Arm Description
Outcomes
Primary Outcome Measures
To determine the maximum-tolerated dose of LBH589
Secondary Outcome Measures
Safety and tolerability assessed by AEs, SAEs and laboratory values.
To characterize the pharmacokinetic (PK) profile of LBH589
To assess antitumor activity of LBH589
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00412997
Brief Title
LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
Official Title
A Phase I Dose-escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The phase I study will evaluate the safety, efficacy and pharmacokinetics of LBH589B in adult patients with advanced solid tumors or Cutaneous T-cell lymphoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors, Cutaneous T-Cell Lymphoma
Keywords
advanced solid tumor, Cutaneous T-cell lymphoma, Phase I, HDAC inhibitor, Adult patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LBH589
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LBH589
Other Intervention Name(s)
panobinostat
Primary Outcome Measure Information:
Title
To determine the maximum-tolerated dose of LBH589
Time Frame
1st cycle
Secondary Outcome Measure Information:
Title
Safety and tolerability assessed by AEs, SAEs and laboratory values.
Time Frame
Every 2 weeks
Title
To characterize the pharmacokinetic (PK) profile of LBH589
Time Frame
every 3 cycles
Title
To assess antitumor activity of LBH589
Time Frame
every 2 cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with either a) histologically-confirmed, advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists, or b) cytopathologically confirmed cutaneous T-cell lymphoma (CTCL) whose disease has progressed despite standard therapy or for whom no standard therapy exists. Inclusion is irrespective of stage of disease or extent of prior therapy.
World Health Organization (WHO) Performance Status of ≤ 2
Patients must have the adequate laboratory values
Exclusion Criteria:
Patients with a history of primary CNS tumors
Patients with any history of brain metastases
Patients with any peripheral neuropathy ≥ CTCAE grade 2
Patients with unresolved diarrhea ≥ CTCAE grade 2
Impairment of cardiac function
Impairment of gastrointestinal (GI) function or GI disease
Liver or renal disease
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
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