Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function
Solid Tumors, Hepatic Impairment

About this trial
This is an interventional treatment trial for Solid Tumors focused on measuring solid tumors, hepatic impairment, Child-Pugh classification, pharmacokinetics, PK, RECIST 1.1
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of California at Los Angeles Dept. of UCLA (4)
- Duke University Medical Center DUMC
- Cancer Therapy & Research Center / UT Health Science Center SC
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
TKI258 normal hepatic function
TKI258 mild hepatic impairment
TKI258 moderate hepatic impairment
TKI258 severe hepatic impairment
TKI258 Capsule, @ 500 mg p.o. o.d. 5 days on/2 days off
TKI258 capsule @ 500 or 400 mg p.o. o.d. 5 days on/2 days off
TKI258 capsule @ starting dose at 400 mg p.o. o.d. 5 days on/2 days off
TKI258 capsule Starting dose to be determined based on the study outcome of the mild and moderate hepatic impairment groups