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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

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


Inclusion Criteria:



1. Patient has documented diagnosis of advanced solid tumor for which no standard
systemic therapy exists

2. Patient has normal or abnormal hepatic organ function

3. Patient has provided written informed consent prior to any screening procedures

Exclusion Criteria:

1. Patient needing valproic acid for any medical condition during the study or within 5
days prior to the first panobinostat dose

2. Patient received prior treatment with DAC inhibitors including panobinostat

3. Patient requires treatment with warfarin that cannot be switched to another
anticoagulant treatment prior to starting study drug

4. Patient has encephalopathy

5. Patient has ascites requiring intervention

6. 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

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.

Outcome Time Frame:

first 7 days

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589X2101

NCT ID:

NCT01007968

Start Date:

March 2010

Completion Date:

November 2012

Related Keywords:

  • Advanced Solid Tumors
  • solid tumors
  • hepatic function
  • advanced
  • panobinostat
  • Neoplasms

Name

Location

University of Utah / Huntsman Cancer InstituteSalt Lake City, Utah  84103