NCT01007968

Brief Summary

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 hepatic function status on panobinostat PK.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2010

Typical duration for phase_1

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 19, 2020

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

October 28, 2009

Last Update Submit

December 16, 2020

Conditions

Advanced Solid Tumors

Keywords

solid tumorshepatic functionadvancedpanobinostat

Outcome Measures

Primary Outcomes (1)

  • To assess the effect of various degrees of impairment in hepatic function as measured by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) criteria, on the pharmacokinetics of panobinostat.

    first 7 days

Secondary Outcomes (3)

  • To assess the effect of various degrees of impairment in hepatic function on the safety of panobinostat

    entire duration of study

  • To evaluate whether there is a relationship between panobinostat PK and safety parameters in patients with various degrees of hepatic organ function

    first 7 days

  • To explore anti-tumor activity associated with panobinostat.

    best overall response

Study Arms (1)

HDACi

EXPERIMENTAL
Drug: LBH589

Interventions

LBH589DRUG
HDACi

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 requires treatment with warfarin that cannot be switched to another anticoagulant treatment prior to starting study drug
  • Patient has encephalopathy
  • Patient has ascites requiring intervention
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Utah / Huntsman Cancer Institute

Salt Lake City, Utah, 84103, United States

Location

Novartis Investigative Site

Leiden, 2300 RC, Netherlands

Location

Novartis Investigative Site

Lund, SE-221 85, Sweden

Location

Novartis Investigative Site

Stockholm, SE-171 76, Sweden

Location

Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

Location

Novartis Investigative Site

Edinburgh, EH4 2XR, United Kingdom

Location

Related Publications (1)

  • Slingerland M, Hess D, Clive S, Sharma S, Sandstrom P, Loman N, Porro MG, Mu S, Waldron E, Valera SZ, Gelderblom H. A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and various degrees of hepatic function. Cancer Chemother Pharmacol. 2014 Nov;74(5):1089-98. doi: 10.1007/s00280-014-2594-6. Epub 2014 Sep 25.

    PMID: 25253045DERIVED

Related Links

MeSH Terms

Interventions

Panobinostat

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic AcidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2009

First Posted

November 5, 2009

Study Start

March 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 19, 2020

Record last verified: 2016-08

Locations

NL(1)GB(1)US(1)SE(2)CH(1)