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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01991678
First received: October 29, 2013
Last updated: August 8, 2017
Last verified: August 2017
  Purpose
The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.

Condition Intervention Phase
Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment Drug: 145 mg/m2 NKTR 102 Drug: 120 mg/m2 NKTR 102 Drug: 50 mg/m2 NKTR 102 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Safety and tolerability of NKTR-102 [ Time Frame: Day 1 through Day 42 ]
    Assessments are: physical examinations, vital signs, ECGs, AEs, and laboratory testing.


Enrollment: 25
Actual Study Start Date: November 2013
Estimated Study Completion Date: September 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: normal hepatic function
12 Patients will receive a 90-minute IV infusion
Drug: 145 mg/m2 NKTR 102
Experimental: mild hepatic dysfunction
6 Patients will receive a 90-minute IV infusion
Drug: 120 mg/m2 NKTR 102
Experimental: severe hepatic dysfunction
6 Patients will receive a 90-minute IV infusion
Drug: 50 mg/m2 NKTR 102

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991678

Locations
United States, California
USC/LA County
Los Angeles, California, United States, 90089
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
United States, Ohio
University Hospitals Case-Medical Center Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Ivan Gergel, MD Nektar Therapeutics
  More Information

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT01991678     History of Changes
Other Study ID Numbers: 12-102-13
Study First Received: October 29, 2013
Last Updated: August 8, 2017

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2017