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

Completed · Phase 1

Conditions studied: Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment

In brief

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

Key facts

Study ID

NCT01991678

Run by

Nektar Therapeutics

People needed

25

Starts

2013-11-01

Expected to finish

2017-09-01

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• USC/LA County — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• University Hospitals Case-Medical Center Seidman Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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