Study of Oral LBH589 in Adult Patients With Refractory/Resistant Cutaneous T-Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00490776
First received: June 21, 2007
Last updated: November 26, 2012
Last verified: November 2012

June 21, 2007
November 26, 2012
June 2007
September 2009   (final data collection date for primary outcome measure)
To determine the overall response rate of patients treated with LBH589 by using the modified Severity-Weighted Assessment Tool to assess skin disease and the evaluation of disease in the viscera, lymph nodes, and blood (circulation SS cells) [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Response rate assessed by: visceral disease, lymph nodes, blood samples and a modified Severity-Weighted Assessment Tool (mSWAT) score to assess skin disease.
Complete list of historical versions of study NCT00490776 on ClinicalTrials.gov Archive Site
  • To determine the response rate using the Physicians Global Assessment of Clinical Condition(PGA)of patients with resistant CTCL [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • To determine the response rate using Modified Severity Weighted Assessment (mSWAT) skin score of patients with resistant CTCL [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Responses in index lesions by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Overall response rate of patients with resistant CTCL treated with oral LBH589 by using the modified Physician's Global Assessment (PGA) to assess skin disease and the evaluation of disease in the viscera, lymph nodes and blood (circulating SS cells). [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Response rate assessed by the Physicians Global Assessment of Clinical Condition (PGA) Responses in index lesions assessed by lesion measurements with photographic supporting documentation
Not Provided
Not Provided
 
Study of Oral LBH589 in Adult Patients With Refractory/Resistant Cutaneous T-Cell Lymphoma
A Phase II Study of Oral LBH589 in Adult Patients With Cutaneous T-Cell Lymphoma Who Are Intolerant to or Have Progressed on or After Prior HDAC Inhibitor

This study will evaluate the safety and efficacy of LBH589B in adult patients with refractory/resistant Cutaneous T-Cell Lymphoma and prior HDAC inhibitor therapy.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cutaneous T-Cell Lymphoma
Drug: LBH589
Other Name: panobinostat
Experimental: LBH589
Intervention: Drug: LBH589
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
Not Provided
September 2009   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Written informed consent obtained prior to any screening procedures
  2. Age greater than or equal to 18 years old
  3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible. Patients with transformed CTCL are eligible.
  4. Patients must have been treated with an HDAC inhibitor given for the treatment of CTCL. Patients must have had disease progression on or following treatment with an HDAC inhibitor. Patients are also eligible if they had an inadequate response to an HDAC inhibitor defined as stable disease as the best response after at least 3 months of therapy. Patients previously treated with an HDAC inhibitor are also eligible if they experienced intolerance due to adverse events.

Exclusion criteria:

  1. Patients with a history of visceral disease including CNS involvement (i.e. stage IVB CTCL). Note, patients who have SS with bone marrow involvement are eligible.
  2. Impaired cardiac function
  3. Concomitant use of drugs with a risk of causing torsades de pointes
  4. Patients who have received chemotherapy or any investigational drug or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  5. Less than 3 months since prior electron beam therapy
  6. Women who are pregnant or breast feeding, or women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study and 3 months after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00490776
CLBH589B2212
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2012

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