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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00739414
First received: August 18, 2008
Last updated: April 16, 2014
Last verified: March 2010

August 18, 2008
April 16, 2014
July 2008
November 2009   (final data collection date for primary outcome measure)
To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors. [ Time Frame: First cycle ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00739414 on ClinicalTrials.gov Archive Site
  • To characterize the pharmacokinetics (PK) of LBH589 [ Time Frame: First cycle ] [ Designated as safety issue: Yes ]
  • To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors [ Time Frame: Every 2 cycle ] [ Designated as safety issue: No ]
  • 1. To characterize the pharmacokinetics (PK) of LBH589 [ Time Frame: 1. First cycle ] [ Designated as safety issue: No ]
  • 2. To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors [ Time Frame: 2. Every 2 cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors
A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Advanced Solid Tumor
Drug: LBH589
10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle
Other Name: Panobinostat
Experimental: LBH589 (Panobinostat)
Intervention: Drug: LBH589
Morita S, Oizumi S, Minami H, Kitagawa K, Komatsu Y, Fujiwara Y, Inada M, Yuki S, Kiyota N, Mitsuma A, Sawaki M, Tanii H, Kimura J, Ando Y. Phase I dose-escalating study of panobinostat (LBH589) administered intravenously to Japanese patients with advanced solid tumors. Invest New Drugs. 2012 Oct;30(5):1950-7. doi: 10.1007/s10637-011-9751-0. Epub 2011 Oct 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
Not Provided
November 2009   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00739414
CLBH589A1101
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
Novartis
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP