A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)
Conditions
Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment
Conditions: official terms
Liver Diseases
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 145 mg/m2 NKTR 102 Type: Drug
Name: 120 mg/m2 NKTR 102 Type: Drug
Name: 95 mg/m2 NKTR 102 Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild or moderate hepatic impairment.
Detailed Description
Safety and PK data from patients with mild or moderate hepatic impairment will be compared with a control group consisting of patients with normal hepatic function.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
USC/LA County
Los Angeles, California, United States
Status: Recruiting
Contact: Jubilee Acap - 323-865-0593 - jubilee.acap@med.usc.edu
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Status: Recruiting
Contact: Jeremy Burbanks-Ivey - 415-514-6248 - Jeremy.Burbanks-Ivey@ucsf.edu
University of Minnesota
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Carrie McCann - 612-626-2569 - mcca0313@umn.edu
University Hospitals Case-Medical Center Seidman Cancer Center
Cleveland, Ohio, United States
Status: Recruiting
Contact: Angela Hughes, MD - 216-844-5176 - angela.hughes@uhhospitals.org
Start Date
November 2013
Completion Date
July 2015
Sponsors
Nektar Therapeutics
Source
Nektar Therapeutics
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page