Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function

Completed · Phase 1

Conditions studied: Solid Tumors, Hepatic Impairment

In brief

This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function. Hepatic function in study patients will be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.

Key facts

Study ID

NCT01443481

Run by

Novartis Pharmaceuticals

People needed

38

Starts

2011-11-01

Expected to finish

2014-10-01

Last updated by the study team

2020-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically or cytologically confirmed solid tumor, excluding breast cancer, that is either refractory to the standard therapy or has no available therapies.
• ECOG performance status (PS) 0 or 1
• 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

You may not qualify if…

• Patients with known brain metastases.
• Patients who have undergone major surgery ≤ 4 weeks prior to starting study treatment
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of California at Los Angeles Dept. of UCLA (4) — Los Angeles, California, United States
• Duke University Medical Center DUMC — Durham, North Carolina, United States
• Cancer Therapy & Research Center / UT Health Science Center SC — San Antonio, Texas, United States
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Rozzano, MI, Italy
• Novartis Investigative Site — Verona, VR, Italy
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Maastricht, Netherlands
• Novartis Investigative Site — Singapore, Singapore

Full record on ClinicalTrials.gov

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