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

NCT01976143 | Completed Phase 1

• 1 other identifier: 12-102-12
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

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

Conditions

Advanced Cancer; Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• QTcF interval values

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

  Day -1 through Day 42

Secondary Outcomes (1)

• Pharmacokinetics (PK) and ECG Parameters

  Day 1 through Day 42

Study Arms (1)

NKTR-102

EXPERIMENTAL

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

Drug: NKTR-102

Interventions

NKTR-102 DRUG

NKTR-102

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (3)

American Institute of Research, Los Angeles

Los Angeles, California, 90017, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

University Hospitals Case-Medical Center Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

etirinotecan pegol

Study Officials

• Ivan Gergel, MD

  Nektar Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 5, 2013
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

US (3)