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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.

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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.

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

FieldValue
Enrollment Target 25 participants
Start Date 2013-11
Est. Completion 2017-09
Phase Phase 1

Sponsor

Nektar Therapeutics

37 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.