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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: August 18, 2008
Last updated: April 16, 2014
Last verified: March 2010
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 Intervention Phase
Cancer Advanced Solid Tumor Drug: LBH589 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

Enrollment: 14
Study Start Date: July 2008
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00739414

Novartis Investigational Site
Aichi prefecture, Japan
Novartis Investigational Site
Hokkaido, Japan
Novartis Investigational Site
Hyogo prefecture, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00739414     History of Changes
Other Study ID Numbers: CLBH589A1101
Study First Received: August 18, 2008
Last Updated: April 16, 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Histone Deacetylases
HDAC inhibitor
Advanced solid tumor

Additional relevant MeSH terms:
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017