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A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)
NCT01991678 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01991678 reports 3 study locations spanning 2 distinct geographic areas — top geographies include California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01991678?
This trial is sponsored by Nektar Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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