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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01991678

Enrollment

Registered

2013-11-25

Start date

2013-11-30

Completion date

2017-09-30

Last updated

2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment

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.

Interventions

DRUG145 mg/m2 NKTR 102

DRUG120 mg/m2 NKTR 102

DRUG50 mg/m2 NKTR 102

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics (PK) of NKTR-102 and its metabolites	Day 1 through Day 42	1 pre-dose PK measurements 14 post-dose PK measurements

Secondary

Measure	Time frame	Description
Safety and tolerability of NKTR-102	Day 1 through Day 42	Assessments are: physical examinations, vital signs, ECGs, AEs, and laboratory testing.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026