The purpose of this research study is to evaluate the effect of NKTR-102 on the QT/QTc interval in patients with advanced or metastatic solid tumors
This is an open-label study that will assess the effect of NKTR- 102 on cardiac ventricular repolarization, as characterized by QTcF (QT interval with Fridericia correction) interval values, in patients with advanced or metastatic solid tumors following administration of a single dose of NKTR-102.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
American Institute of Research, Los Angeles
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University Hospitals Case-Medical Center Seidman Cancer Center
Cleveland, Ohio, United States
QTcF interval values
10 pre-dose and 18 post-dose ECG measurements to evaluate the effect of NKTR-102
Time frame: Day -1 through Day 42
Pharmacokinetics (PK) and ECG Parameters
1 pre-dose and 18 post-dose blood samples to measure concentrations of NKTR-102 and its metabolites
Time frame: Day 1 through Day 42
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