Back to results

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

Primary Purpose

Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

145 mg/m2 NKTR 102

120 mg/m2 NKTR 102

50 mg/m2 NKTR 102

About this trial

This is an interventional treatment trial for Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Relapsed or progressive advanced solid tumor malignancies
Measurable or non-measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Life expectancy greater than 3 months
Resolution of all acute toxic effects of prior chemotherapy, and other cancer treatments
Adequate bone morrow and kidney function
No signs of decompensated liver cirrhosis or ascites requiring therapeutic paracentesis
Agree to use adequate contraception

Exclusion Criteria:

Previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1
Cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks prior to day 1
Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1
UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1*37)
Major surgery within 4 weeks prior to day 1
Undergone a liver or other organ transplant
Concurrent treatment with other anti-cancer therapy
Untreated central nervous system metastases
Ongoing or active infection
Chronic or acute GI disorders resulting in diarrhea
Pregnancy or lactation

Sites / Locations

USC/LA County
UCSF Helen Diller Family Comprehensive Cancer Center
University Hospitals Case-Medical Center Seidman Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

normal hepatic function

mild hepatic dysfunction

severe hepatic dysfunction

Arm Description

12 Patients will receive a 90-minute IV infusion

6 Patients will receive a 90-minute IV infusion

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK) of NKTR-102 and its metabolites

1 pre-dose PK measurements 14 post-dose PK measurements

Secondary Outcome Measures

Safety and tolerability of NKTR-102

Assessments are: physical examinations, vital signs, ECGs, AEs, and laboratory testing.

Full Information

NCT ID

NCT01991678

First Posted

October 29, 2013

Last Updated

October 5, 2017

Sponsor

Nektar Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01991678

Brief Title

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

Official Title

An Open-Label, Parallel-Group, Multicenter, Phase 1 Study to Investigate the Pharmacokinetics of NKTR-102 for Injection (Etirinotecan Pegol) in Patients With Advanced or Metastatic Solid Tumors and Hepatic Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

November 2013 (Actual)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nektar Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

Safety and PK data from patients with mild, moderate, or severe hepatic impairment will be compared with a control group consisting of patients with normal hepatic function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

normal hepatic function

Arm Type

Experimental

Arm Description

12 Patients will receive a 90-minute IV infusion

Arm Title

mild hepatic dysfunction

Arm Type

Experimental

Arm Description

6 Patients will receive a 90-minute IV infusion

Arm Title

severe hepatic dysfunction

Arm Type

Experimental

Arm Description

6 Patients will receive a 90-minute IV infusion

Intervention Type

Drug

Intervention Name(s)

145 mg/m2 NKTR 102

Intervention Type

Drug

Intervention Name(s)

120 mg/m2 NKTR 102

Intervention Type

Drug

Intervention Name(s)

50 mg/m2 NKTR 102

Primary Outcome Measure Information:

Title

Pharmacokinetics (PK) of NKTR-102 and its metabolites

Description

1 pre-dose PK measurements 14 post-dose PK measurements

Time Frame

Day 1 through Day 42

Secondary Outcome Measure Information:

Title

Safety and tolerability of NKTR-102

Description

Assessments are: physical examinations, vital signs, ECGs, AEs, and laboratory testing.

Time Frame

Day 1 through Day 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Relapsed or progressive advanced solid tumor malignancies Measurable or non-measurable disease Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Life expectancy greater than 3 months Resolution of all acute toxic effects of prior chemotherapy, and other cancer treatments Adequate bone morrow and kidney function No signs of decompensated liver cirrhosis or ascites requiring therapeutic paracentesis Agree to use adequate contraception Exclusion Criteria: Previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1 Cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks prior to day 1 Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1 UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1*37) Major surgery within 4 weeks prior to day 1 Undergone a liver or other organ transplant Concurrent treatment with other anti-cancer therapy Untreated central nervous system metastases Ongoing or active infection Chronic or acute GI disorders resulting in diarrhea Pregnancy or lactation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ivan Gergel, MD

Organizational Affiliation

Nektar Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

USC/LA County

City

Los Angeles

State/Province

California

ZIP/Postal Code

90089

Country

United States

Facility Name

UCSF Helen Diller Family Comprehensive Cancer Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

University Hospitals Case-Medical Center Seidman Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs