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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Nektar Therapeutics
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01991678
First received: October 29, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild or moderate 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: 95 mg/m2 NKTR 102
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 Mild or Moderate Hepatic Impairment

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Assessments are: physical examinations, vital signs, ECGs, AEs, and laboratory testing.


Estimated Enrollment: 24
Study Start Date: November 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: May 2015 (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: moderate hepatic dysfunction
6 Patients will receive a 90-minute IV infusion
Drug: 95 mg/m2 NKTR 102

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Contacts
Contact: Ivan Gergel, MD 415-482-5718 IGergel@nektar.com
Contact: Deirdre BeVard, BS 415-482-5694 DBeVard@nektar.com

Locations
United States, California
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90089
Contact: Zeno Ashai    323-865-0463    Zeno.Ashai@med.usc.edu   
Principal Investigator: Anthony El-Khoueiry, MD         
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94143
Contact: Paula Fiermonte, MD    415-885-7605    fiermontep@cc.ucsf.edu   
Principal Investigator: Pamela Munster, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Carrie McCann    612-626-2569    mcca0313@umn.edu   
Principal Investigator: Edward Greeno, Jr., MD         
United States, Ohio
Seidman Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Robin Norris, MD    216-844-3345    Robin.Norris@UHhospitals.org   
Principal Investigator: Robin Norris, MD         
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Ivan Gergel, MD Nektar Therapeutics
  More Information

No publications provided

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 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 23, 2014