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Completed

NCT Number: NCT00739414

Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors

This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists.

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Key information

Conditions

Cancer Advanced Solid Tumor Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigational Site, Aichi Prefecture, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists.
  • At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors
  • Age ≥20 years old
  • World Health Organization (WHO) Performance Status of ≤2
  • Patients must have the following laboratory values as defined in protocol
  • Life expectancy of ≥ 12 weeks
  • Written informed consent obtained

Exclusion criteria

  • Patients with evidence of CNS tumor or metastasis
  • Patients with pleural effusion and/or ascites to be drained
  • Patients with any peripheral neuropathy ≥ CTCAE grade 2
  • Impaired cardiac function defined in protocol
  • Acute or chronic liver or renal disease
  • Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
  • Patients who are currently receiving treatment with any of the medications which have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication
  • Patients who have received chemotherapy ≤4 weeks prior to starting study drug or who have not recovered from side effects of such therapy

Treatment and study plan

LBH589

Drug

10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle

Other names: Panobinostat

Primary outcomes

  1. To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors.

    Time frame: First cycle

Secondary outcomes

  1. To characterize the pharmacokinetics (PK) of LBH589

    Time frame: First cycle

  2. To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors

    Time frame: Every 2 cycle

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors

Important dates

Study start
2008
Primary completion
2009
First posted
Aug 21, 2008
Registry last updated
Dec 19, 2020

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.

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