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OpenTrials
Completed

NCT Number: NCT00412997

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBH589

Drug

Other names: panobinostat

Primary outcomes

  1. To determine the maximum-tolerated dose of LBH589

    Time frame: 1st cycle

Secondary outcomes

  1. Safety and tolerability assessed by AEs, SAEs and laboratory values.

    Time frame: Every 2 weeks

  2. To characterize the pharmacokinetic (PK) profile of LBH589

    Time frame: every 3 cycles

  3. To assess antitumor activity of LBH589

    Time frame: every 2 cycles

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
First posted
Dec 19, 2006
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.