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The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal hepatic function | Experimental | 12 Patients will receive a 90-minute IV infusion |
|
| mild hepatic dysfunction | Experimental | 6 Patients will receive a 90-minute IV infusion |
|
| severe hepatic dysfunction | Experimental | 6 Patients will receive a 90-minute IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 145 mg/m2 NKTR 102 | Drug |
| ||
| 120 mg/m2 NKTR 102 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of NKTR-102 and its metabolites | 1 pre-dose PK measurements 14 post-dose PK measurements | Day 1 through Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of NKTR-102 | Assessments are: physical examinations, vital signs, ECGs, AEs, and laboratory testing. | Day 1 through Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Gergel, MD | Nektar Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/LA County | Los Angeles | California | 90089 | United States | ||
| UCSF Helen Diller Family Comprehensive Cancer Center |
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|
| 50 mg/m2 NKTR 102 | Drug |
|
| San Francisco |
| California |
| 94143 |
| United States |
| University Hospitals Case-Medical Center Seidman Cancer Center | Cleveland | Ohio | 44106 | United States |