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

Phase 1

Completed

• Conditions: Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment
• Interventions: Drug: 50 mg/m2 NKTR 102; Drug: 145 mg/m2 NKTR 102; Drug: 120 mg/m2 NKTR 102

• Registration Number: NCT01991678
• Lead Sponsor: Nektar Therapeutics

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.

Study Timeline

• Study First Submitted: 2013-10-29
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2017-05
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
severe hepatic dysfunction	50 mg/m2 NKTR 102	6 Patients will receive a 90-minute IV infusion
normal hepatic function	145 mg/m2 NKTR 102	12 Patients will receive a 90-minute IV infusion
mild hepatic dysfunction	120 mg/m2 NKTR 102	6 Patients will receive a 90-minute IV infusion

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of NKTR-102 and its metabolites	Day 1 through Day 42	1 pre-dose PK measurements 14 post-dose PK measurements

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of NKTR-102	Day 1 through Day 42	Assessments are: physical examinations, vital signs, ECGs, AEs, and laboratory testing.

Trial Locations

Locations (3)

University Hospitals Case-Medical Center Seidman Cancer Center; 🇺🇸 Cleveland, Ohio, United States

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

USC/LA County; 🇺🇸 Los Angeles, California, United States