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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors

Thank you

Trial Information

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


Inclusion Criteria:



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

2. Patient has normal or abnormal renal 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 requiring dialysis

4. Patient requiring diuretics unless patient is taking potassium sparring diuretics

5. Patient has acute renal failure, history of transplant, ESRD (however acceptable
severe renal impaired group)

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 varying degrees of renal function as defined by creatinine clearance), 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:

CLBH589X2105

NCT ID:

NCT00997399

Start Date:

February 2010

Completion Date:

June 2014

Related Keywords:

  • Advanced Solid Tumors
  • Ph I
  • panobinostat (DACi)
  • PK & safety
  • solid tumors
  • varying renal function
  • advanced
  • Neoplasms

Name

Location

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