MedDataX Logo

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

NCT ID: NCT01976143

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Cancer Metastatic Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NKTR-102

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

Group Type EXPERIMENTAL

NKTR-102

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NKTR-102

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nektar Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ivan Gergel, MD

Role: STUDY_DIRECTOR

Nektar Therapeutics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

American Institute of Research, Los Angeles

Los Angeles, California, United States

Site Status

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status

University Hospitals Case-Medical Center Seidman Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-102-12

Identifier Type: -

Identifier Source: org_study_id