Trials / Completed
CompletedNCT01991678
A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)
An Open-Label, Parallel-Group, Multicenter, Phase 1 Study to Investigate the Pharmacokinetics of NKTR-102 for Injection (Etirinotecan Pegol) in Patients With Advanced or Metastatic Solid Tumors and Hepatic Impairment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Nektar Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.
Detailed description
Safety and PK data from patients with mild, moderate, or severe hepatic impairment will be compared with a control group consisting of patients with normal hepatic function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 145 mg/m2 NKTR 102 | |
| DRUG | 120 mg/m2 NKTR 102 | |
| DRUG | 50 mg/m2 NKTR 102 |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2017-05-01
- Completion
- 2017-09-01
- First posted
- 2013-11-25
- Last updated
- 2017-10-06
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01991678. Inclusion in this directory is not an endorsement.