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A Phase I Dose-escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma


Phase 1
20 Years
N/A
Not Enrolling
Both
Tumors, Cutaneous T-Cell Lymphoma

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Trial Information

A Phase I Dose-escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma


Inclusion Criteria:



- Patients with either a) histologically-confirmed, advanced solid tumors whose disease
has progressed despite standard therapy or for whom no standard therapy exists, or b)
cytopathologically confirmed cutaneous T-cell lymphoma (CTCL) whose disease has
progressed despite standard therapy or for whom no standard therapy exists. Inclusion
is irrespective of stage of disease or extent of prior therapy.

- World Health Organization (WHO) Performance Status of ≤ 2

- Patients must have the adequate laboratory values

Exclusion Criteria:

- Patients with a history of primary CNS tumors

- Patients with any history of brain metastases

- Patients with any peripheral neuropathy ≥ CTCAE grade 2

- Patients with unresolved diarrhea ≥ CTCAE grade 2

- Impairment of cardiac function

- Impairment of gastrointestinal (GI) function or GI disease

- Liver or renal disease

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum-tolerated dose of LBH589

Outcome Time Frame:

1st cycle

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

CLBH589B1101

NCT ID:

NCT00412997

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Tumors
  • Cutaneous T-cell Lymphoma
  • advanced solid tumor
  • Cutaneous T-cell lymphoma
  • Phase I
  • HDAC inhibitor
  • Adult patients
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

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