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NCT01991678 · ClinicalTrials.gov registry record · Phase 1
A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)
A Phase 1 study of Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment, sponsored by Nektar Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 3
- Study locations
NCT01991678 is a Phase 1 study of Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment that has completed, run by Nektar Therapeutics. The registered enrollment target is 25 participants. The trial reports 3 study locations across 2 states.
The verdict
NCT01991678, a Phase 1 study of Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment, has completed, sponsored by Nektar Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG 145 mg/m2 NKTR 102
- DRUG 120 mg/m2 NKTR 102
- DRUG 50 mg/m2 NKTR 102
Study Locations (3)
California
- USC/LA County - Los Angeles
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Ohio
- University Hospitals Case-Medical Center Seidman Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01991678
The ClinicalTrials.gov registry entry for NCT01991678 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nektar Therapeutics, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment appearing as the primary indexed condition, and to 3 interventions - of which 145 mg/m2 NKTR 102 is the first listed.
NCT01991678 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, Ohio.
Frequently Asked Questions
What is clinical trial NCT01991678 about?
NCT01991678 is a clinical study titled "A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)". The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.
What is the current status of trial NCT01991678?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2013-11. Estimated completion is 2017-09.
What conditions does trial NCT01991678 study?
This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment.
What interventions are being tested in trial NCT01991678?
The interventions under investigation include: 145 mg/m2 NKTR 102 (DRUG), 120 mg/m2 NKTR 102 (DRUG), 50 mg/m2 NKTR 102 (DRUG).
Who is sponsoring clinical trial NCT01991678?
This trial is sponsored by Nektar Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01991678 being conducted?
This trial has 3 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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