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NCT Number: NCT00997399

Study to Evaluate Panobinostat (DACi) Pharmacokinetics and Safety in Solid Tumors and Varying Renal Function

Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients with solid tumors and hematological malignancies.

To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with solid tumors and hematological malignancies participating in several phase I/II clinical studies. Panobinostat PK does not appear to be different in patients with solid tumors and hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is yet to be elucidated.

Kidney and liver are involved in the elimination and metabolism of panobinostat. The current study is designed to evaluate the impact of renal function status on panobinostat PK.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Leiden, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has documented diagnosis of advanced solid tumor for which no standard systemic therapy exists
  • Patient has normal or abnormal renal organ function
  • Patient has provided written informed consent prior to any screening procedures

Exclusion criteria

  • Patient needing valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose
  • Patient received prior treatment with DAC inhibitors including panobinostat
  • Patient requiring dialysis
  • Patient requiring diuretics unless patient is taking potassium sparring diuretics
  • Patient has acute renal failure, history of transplant, ESRD (however acceptable severe renal impaired group)
  • Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Panobinostat (LBH589)

Drug

Primary outcomes

  1. To assess the effect of varying degrees of renal function as defined by creatinine clearance), on the pharmacokinetics of panobinostat.

    Time frame: First 7 days

Secondary outcomes

  1. To assess the effect of varying degrees of renal function on the safety of panobinostat

    Time frame: Entire duration of study

  2. To evaluate whether there is a relationship between PK and safety parameters in patients with varying degrees of renal function.

    Time frame: 7 days

  3. To explore anti-tumor activity associated with panobinostat.

    Time frame: 6 months (6 cycles)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase I, Open-label, Multi-center Study to Evaluate the Pharmacokinetics and Safety of Oral Panobinostat in Patients With Advanced Solid Tumors and Varying Degrees of Renal Function

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 19, 2009
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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