A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)

An Open-Label, Parallel-Group, Multicenter, Phase 1 Study to Investigate the Pharmacokinetics of NKTR-102 for Injection (Etirinotecan Pegol) in Patients With Advanced or Metastatic Solid Tumors and Hepatic Impairment

The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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