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A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)

NCT01991678 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-10-06

No results posted yet for this 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

  • Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment

Interventions

DRUG

145 mg/m2 NKTR 102

DRUG

120 mg/m2 NKTR 102

DRUG

50 mg/m2 NKTR 102

Sponsors & Collaborators

Principal Investigators

  • Ivan Gergel, MD · Nektar Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-05-31
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991678 on ClinicalTrials.gov