LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00412997

Enrollment

Registered

2006-12-19

Start date

2006-11-30

Completion date

Unknown

Last updated

2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous T-Cell Lymphoma, Tumors

Keywords

advanced solid tumor, Cutaneous T-cell lymphoma, Phase I, HDAC inhibitor, Adult patients

Brief summary

The phase I study will evaluate the safety, efficacy and pharmacokinetics of LBH589B in adult patients with advanced solid tumors or Cutaneous T-cell lymphoma

Interventions

DRUGLBH589

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
To determine the maximum-tolerated dose of LBH589	1st cycle

Secondary

Measure	Time frame
Safety and tolerability assessed by AEs, SAEs and laboratory values.	Every 2 weeks
To characterize the pharmacokinetic (PK) profile of LBH589	every 3 cycles
To assess antitumor activity of LBH589	every 2 cycles

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026