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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00425555
First received: January 22, 2007
Last updated: April 2, 2014
Last verified: December 2013

January 22, 2007
April 2, 2014
January 2007
June 2013   (final data collection date for primary outcome measure)
Response rate assessed by: visceral disease, lymph nodes, blood,samples and a modified Severity-Weighted Assessment Tool (mSWAT) score to assess skin disease [ 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 NCT00425555 on ClinicalTrials.gov Archive Site
  • Response rate assessed by the Physicians Global Assessment of Clinical Condition (PGA) [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Responses in index lesions assessed by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Improvement in Cutaneous T-Cell Lymphoma (CTCL)-related symptoms and patient-reported outcomes [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Safety and tolerability assessed by adverse events, serious adverse events and/or dose de-escalation [ Time Frame: Every Visit ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (PK) profile of LBH589 [ Time Frame: 1st month of treatment ] [ 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
  • Improvement in Cutaneous T-Cell Lymphoma (CTCL)-related symptoms and patient-reported outcomes
  • Safety and tolerability assessed by adverse events, serious adverse events and/or dose de-escalation
  • Pharmacokinetic (PK) profile of LBH589
Not Provided
Not Provided
 
Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma

This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cutaneous T-Cell Lymphoma
Drug: Panobinostat
Other Name: LBH589
  • Experimental: Previously treated with oral bexarotene
    Intervention: Drug: Panobinostat
  • Experimental: No prior oral bexarotene treatmemt
    Intervention: Drug: Panobinostat
Duvic M, Dummer R, Becker JC, Poulalhon N, Ortiz Romero P, Grazia Bernengo M, Lebbé C, Assaf C, Squier M, Williams D, Marshood M, Tai F, Prince HM. Panobinostat activity in both bexarotene-exposed and -naïve patients with refractory cutaneous T-cell lymphoma: results of a phase II trial. Eur J Cancer. 2013 Jan;49(2):386-94. doi: 10.1016/j.ejca.2012.08.017. Epub 2012 Sep 13. PubMed PMID: 22981498.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Written informed consent obtained prior to any screening procedures
  2. Age ≥ 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.
  4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA, photophoresis, chemotherapy such as methotrexate, and interferon. Topical steroids alone are not considered as a treatment regimen.
  5. Patients must have had disease progression on or following their most recent treatment regimen or an inadequate response to their most recent treatment regimen.
  6. Patients will be accrued to one of two groups: Patients previously treated with oral bexarotene and patients who have not had prior oral bexarotene treatment.

Exclusion criteria:

  1. Prior treatment with an HDAC inhibitor.
  2. Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note; Patients with SS who have bone marrow involvement are eligible.
  3. Impaired cardiac function
  4. Concomitant use of drugs with a risk of causing torsades de pointes
  5. Patients who have received chemotherapy or any investigational drug or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  6. Less than 3 months since prior electron beam therapy
  7. Female patients who are pregnant or breast feeding, or patients of reproductive potential not using an effective method of birth control, and male patients whose sexual partners are women of childbearing potential not using effective birth control 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,   Belgium,   Italy,   Spain,   Argentina,   Australia,   Switzerland,   Canada,   Finland,   France,   Germany,   Hungary
 
NCT00425555
CLBH589B2201, 2006-000880-27
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2013

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