- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01991678
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
Status
Completed
Intervention / Treatment
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
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California
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Los Angeles, California, United States, 90089
- USC/LA County
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San Francisco, California, United States, 94143
- UCSF Helen Diller Family Comprehensive Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Case-Medical Center Seidman Cancer Center
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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
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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
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Day 1 through Day 42
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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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-102-13
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.
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