A Study to Investigate the Effect of Food on Oral LBH589 Absorption in Patients With Advanced Solid Tumors
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00570284
First received: December 7, 2007
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
The primary purpose of this study is to evaluate the effect of food on oral LBH589 in adult patients with advanced solid tumors. This study will also evaluate the safety and efficacy of LBH589 in adult patients with advanced solid tumors
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: LBH589 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ib Open-label, Multicenter Cross-over Study to Investigate the Effect of Food on the Rate and Extent of Oral LBH589 Absorption in Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Levels of LBH589 in the blood [ Time Frame: every week for the first 3 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy, Safety and tolerability [ Time Frame: throughout study to 28 days after last treatment ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | November 2007 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LBH589 |
Drug: LBH589
orally administered panobinostat at 20 mg twice weekly (core phase); orally administered panobinostat 45 mg twice weekly if 20 mg twice weekly was tolerated in Cycle 1 (extension phase)
Other Name: Panobinostat
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists
- Age ≥ 18 years old
- Patients must have adequate laboratory values
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Ability to swallow capsules or tablets
Exclusion criteria:
- Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
- Patients with a second primary malignancy that is currently clinically significant or requiring active intervention
- Impaired heart function or clinically significant heart disease
- Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589
- Ongoing diarrhea
- Liver or renal disease with impaired hepatic or renal functions
- Concomitant use of any anti-cancer therapy or certain drugs
- Female patients who are pregnant or breast feeding
- Patients not willing to use an effective method of birth control
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570284
Locations
| United States, California | |
| Novartis Investigative Site | |
| Los Angeles, California, United States | |
| United States, Connecticut | |
| Novartis Investigative Site | |
| Norwalk, Connecticut, United States | |
| United States, Maryland | |
| Novartis Investigative Site | |
| Rockville, Maryland, United States | |
| United States, Massachusetts | |
| Novartis Investigative Site | |
| Boston, Massachusetts, United States | |
| United States, New Hampshire | |
| Novartis Investigative Site | |
| Lebanon, New Hampshire, United States | |
| United States, New York | |
| Novartis Investigative Site | |
| New York, New York, United States | |
| United States, Wisconsin | |
| Novartis Investigative Site | |
| Madison, Wisconsin, United States | |
| Sweden | |
| Novartis Investigative Site | |
| Stokholm, Sweden | |
| Switzerland | |
| Novartis Investigative Site | |
| Zurich, Switzerland | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Chair: | Novartis | Novartis |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00570284 History of Changes |
| Other Study ID Numbers: | CLBH589B2111 |
| Study First Received: | December 7, 2007 |
| Last Updated: | November 26, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board Switzerland: Swissmedic United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Cancer solid tumor food effect |
HDAC inhibitor oral LBH589 |
ClinicalTrials.gov processed this record on May 22, 2013