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

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