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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: Completed Phase 1 study of Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment, sponsored by Nektar Therapeutics.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
1 pre-dose PK measurements 14 post-dose PK measurements
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 |
What the finished NCT01991678 record still lists
NCT01991678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01991678's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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