Status:
COMPLETED
Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Solid Tumors
Hepatic Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01443481
Start Date
November 1 2011
End Date
October 1 2014
Last Update
December 21 2020
Active Locations (12)
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1
University of California at Los Angeles Dept. of UCLA (4)
Los Angeles, California, United States, 90095
2
Duke University Medical Center DUMC
Durham, North Carolina, United States, 27710
3
Cancer Therapy & Research Center / UT Health Science Center SC
San Antonio, Texas, United States, 78229
4
Novartis Investigative Site
Ghent, Belgium, 9000