Overview

This trial is active, not recruiting.

Conditions advanced cancer, metastatic solid tumors
Treatment nktr-102
Phase phase 1
Sponsor Nektar Therapeutics
Start date February 2014
End date June 2016
Trial size 33 participants
Trial identifier NCT01976143, 12-102-12

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
A single 90 minute IV infusion of 220 mg/m2 NKTR-102
nktr-102

Primary Outcomes

Measure
QTcF interval values
time frame: Day -1 through Day 42

Secondary Outcomes

Measure
Pharmacokinetics (PK) and ECG Parameters
time frame: Day 1 through Day 42

Eligibility Criteria

Male or female participants at least 18 years old.

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 UGT1A1*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1*37) - 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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Nektar Therapeutics.
Location data was received from the National Cancer Institute and was last updated in July 2016.