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

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nektar Therapeutics
• Treatments: Etirinotecan pegol

Criteria

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