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A Multi-center, Open Label Study to Assess Pharmacokinetics of TKI258 in Adult Cancer Patients With Normal and Impaired Hepatic Function


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors, Hepatic Impairment

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Trial Information

A Multi-center, Open Label Study to Assess Pharmacokinetics of TKI258 in Adult Cancer Patients With Normal and Impaired Hepatic Function


Inclusion Criteria:



1. Patients with histologically or cytologically confirmed solid tumor, excluding breast
cancer, that is either refractory to the standard therapy or has no available
therapies.

2. ECOG performance status (PS) 0 or 1

3. Patients must have measurable and/or non-measurable lesion(s) as assessed by Computer
Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) per RECIST 1.1

Exclusion Criteria:

1. Patients with known brain metastases.

2. Patients who have undergone major surgery ≤ 4 weeks prior to starting 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, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetic (PK) parameter of Cmax following a single dose of TKI258 and at the steady state

Outcome Description:

Cmax will be evaluated after a single dose of TKI258 and at the steady state following a 5 days on/2 days off dosing schedule. Cmax is the maximum (peak) plasma, blood, serum, or other body fluid drug concentration after a single dose administration (mass x volume - 1).

Outcome Time Frame:

Day 1, Day 19

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2124

NCT ID:

NCT01443481

Start Date:

November 2011

Completion Date:

September 2014

Related Keywords:

  • Solid Tumors
  • Hepatic Impairment
  • solid tumors
  • hepatic impairment
  • Child-Pugh classification
  • pharmacokinetics
  • PK
  • RECIST 1.1
  • Liver Diseases

Name

Location
Duke University Medical Center DUMC Durham, North Carolina  27710
Cancer Therapy & Research Center / UT Health Science Center SC San Antonio, Texas  78229
University of California at Los Angeles Dept. of UCLA (4) Los Angeles, California  90095