Trials / Completed
CompletedNCT01976143
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
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Nektar Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NKTR-102 |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2016-06-01
- Completion
- 2016-09-01
- First posted
- 2013-11-05
- Last updated
- 2016-12-22
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01976143. Inclusion in this directory is not an endorsement.