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

October 5, 2017 updated by: Nektar Therapeutics

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90089
        • USC/LA County
      • San Francisco, California, United States, 94143
        • UCSF Helen Diller Family Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case-Medical Center Seidman Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: normal hepatic function
12 Patients will receive a 90-minute IV infusion
EXPERIMENTAL: mild hepatic dysfunction
6 Patients will receive a 90-minute IV infusion
EXPERIMENTAL: severe hepatic dysfunction
6 Patients will receive a 90-minute IV infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2013

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment

Clinical Trials on 145 mg/m2 NKTR 102

3
Subscribe