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Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00739414
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists.

Condition or disease Intervention/treatment Phase
Cancer Advanced Solid Tumor Drug: LBH589 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors
Study Start Date : July 2008
Actual Primary Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LBH589 (Panobinostat) Drug: LBH589
10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle
Other Name: Panobinostat

Primary Outcome Measures :
  1. To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors. [ Time Frame: First cycle ]

Secondary Outcome Measures :
  1. To characterize the pharmacokinetics (PK) of LBH589 [ Time Frame: First cycle ]
  2. To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors [ Time Frame: Every 2 cycle ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists.
  2. At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors
  3. Age ≥20 years old
  4. World Health Organization (WHO) Performance Status of ≤2
  5. Patients must have the following laboratory values as defined in protocol
  6. Life expectancy of ≥ 12 weeks
  7. Written informed consent obtained

Exclusion Criteria:

  1. Patients with evidence of CNS tumor or metastasis
  2. Patients with pleural effusion and/or ascites to be drained
  3. Patients with any peripheral neuropathy ≥ CTCAE grade 2
  4. Impaired cardiac function defined in protocol
  5. Acute or chronic liver or renal disease
  6. Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
  7. Patients who are currently receiving treatment with any of the medications which have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication
  8. Patients who have received chemotherapy ≤4 weeks prior to starting study drug or who have not recovered from side effects of such therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00739414

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Novartis Investigational Site
Aichi prefecture, Japan
Novartis Investigational Site
Hokkaido, Japan
Novartis Investigational Site
Hyogo prefecture, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00739414    
Other Study ID Numbers: CLBH589A1101
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: March 2010
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Histone Deacetylases
HDAC inhibitor
Advanced solid tumor
Additional relevant MeSH terms:
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Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action