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
Description
Brief 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.
Detailed Description
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.
Phase
N/AInclusion and Exclusion 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
- 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
Sites
-
California
- USC/Norris Comprehensive Cancer Center, Los Angeles, California, 90089
- UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, 94143
-
Minnesota
- University of Minnesota, Minneapolis, Minnesota, 55455
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