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A Study in Cancer Patients to Evaluate the Effect of a Single Dose of NKTR-102 (Etirinotecan Pegol) on the QTc Interval and to Assess Pharmacokinetics and Safety

Sponsor
Nektar Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT01976143
Collaborator
(none)
33
Enrollment
3
Locations
1
Arm
31
Duration (Months)
11
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to evaluate the effect of NKTR-102 on the QT/QTc interval in patients with advanced or metastatic solid tumors

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This is an open-label study that will assess the effect of NKTR- 102 on cardiac ventricular repolarization, as characterized by QTcF (QT interval with Fridericia correction) interval values, in patients with advanced or metastatic solid tumors following administration of a single dose of NKTR-102.

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study to Evaluate the Effect of Nktr-102 for Injection (Etirinotecan Pegol) on the QT/QTC Interval in Patients With Advanced or Metastatic Solid Tumors
Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: NKTR-102

A single 90 minute IV infusion of 220 mg/m2 NKTR-102

Drug: NKTR-102

Outcome Measures

Primary Outcome Measures

  1. QTcF interval values [Day -1 through Day 42]

    10 pre-dose and 18 post-dose ECG measurements to evaluate the effect of NKTR-102

Secondary Outcome Measures

  1. Pharmacokinetics (PK) and ECG Parameters [Day 1 through Day 42]

    1 pre-dose and 18 post-dose blood samples to measure concentrations of NKTR-102 and its metabolites

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Advanced or metastatic solid tumor refractory to standard therapy

  • Measurable or non-measurable disease

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

  • Resolution of acute toxic effects of prior chemotherapy and other cancer treatments

  • Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram

  • Adequate bone morrow and organ function

  • Electrolytes within normal limits

  • Stopped tobacco use for 4 weeks prior to day 1 and during the study

  • Agree to use adequate contraception

Exclusion Criteria:

  • Previous anti-cancer therapy for malignancy within 4 weeks (6 weeks for the nitrosoureas or mitomycin C) before day 1

  • Treatment with antiarrythmic drugs and any medication known to cause QTc prolongation within 4 weeks before screening and during the study

  • Prior extensive anthracycline exposure

  • Administration of cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks before day 1 and during the study

  • Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1 and during the study

  • History of serious cardiovascular disease

  • Abnormal systolic blood pressure, diastolic blood pressure and/or heart rate

  • History of additional risk factors for Torsade de Pointes

  • Prolonged QTcF

  • Important abnormalities of the ECG that may interfere with the interpretation of QTc interval changes at screening

  • Implantable pacemaker or automatic implantable cardioverter defibrillator

  • UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A128) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A137)

  • Any major surgery within 4 weeks prior to day 1

  • Concurrent treatment with other anticancer therapy

  • Untreated central nervous system metastases

  • Chronic or acute GI disorders resulting in diarrhea

  • Pregnancy or lactation

Contacts and Locations

Locations

Site City State Country Postal Code
1 American Institute of Research, Los Angeles Los Angeles California United States 90017
2 UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California United States 94143
3 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01976143
Other Study ID Numbers:
  • 12-102-12
First Posted:
Nov 5, 2013
Last Update Posted:
Dec 22, 2016
Last Verified:
Dec 1, 2016
Additional relevant MeSH terms:
Etirinotecan pegol

Study Results

No Results Posted as of Dec 22, 2016