A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)
NCT ID: NCT01991678
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2013-11-30
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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normal hepatic function
12 Patients will receive a 90-minute IV infusion
145 mg/m2 NKTR 102
mild hepatic dysfunction
6 Patients will receive a 90-minute IV infusion
120 mg/m2 NKTR 102
severe hepatic dysfunction
6 Patients will receive a 90-minute IV infusion
50 mg/m2 NKTR 102
Interventions
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145 mg/m2 NKTR 102
120 mg/m2 NKTR 102
50 mg/m2 NKTR 102
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Ivan Gergel, MD
Role: STUDY_DIRECTOR
Nektar Therapeutics
Locations
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USC/LA County
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University Hospitals Case-Medical Center Seidman Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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12-102-13
Identifier Type: -
Identifier Source: org_study_id