Clareo Health | A Study in Cancer Patients to Evaluate the Effect of a Single Dose of NKTR-102 (Etirinotecan Pegol) on the QTc Interval and to Assess Pharmacokinetics and Safety
A Study in Cancer Patients to Evaluate the Effect of a Single Dose of NKTR-102 (Etirinotecan Pegol) on the QTc Interval and to Assess Pharmacokinetics and Safety
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nektar Therapeutics
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Advanced or metastatic solid tumor refractory to standard therapy
Measurable or non-measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Resolution of acute toxic effects of prior chemotherapy and other cancer treatments
Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram
Adequate bone morrow and organ function
Electrolytes within normal limits
Stopped tobacco use for 4 weeks prior to day 1 and during the study
Agree to use adequate contraception
You may not be if
Previous anti-cancer therapy for malignancy within 4 weeks (6 weeks for the nitrosoureas or mitomycin C) before day 1
Treatment with antiarrythmic drugs and any medication known to cause QTc prolongation within 4 weeks before screening and during the study
Prior extensive anthracycline exposure
Administration of cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks before day 1 and during the study
Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1 and during the study
