Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nektar Therapeutics
Safety and PK data from patients with mild, moderate, or severe hepatic impairment will be compared with a control group consisting of patients with normal hepatic function.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Relapsed or progressive advanced solid tumor malignancies
Measurable or non-measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Life expectancy greater than 3 months
Resolution of all acute toxic effects of prior chemotherapy, and other cancer treatments
Adequate bone morrow and kidney function
No signs of decompensated liver cirrhosis or ascites requiring therapeutic paracentesis
Agree to use adequate contraception
You may not be if
Previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1
Cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks prior to day 1
Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1
UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1\*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1\*37)
Major surgery within 4 weeks prior to day 1
Undergone a liver or other organ transplant
Concurrent treatment with other anti-cancer therapy
Untreated central nervous system metastases
Ongoing or active infection
Chronic or acute GI disorders resulting in diarrhea
Pregnancy or lactation
Clareo Health | A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)
