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This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Normal renal function |
|
| Cohort 2 | Experimental | Moderate renal impairment |
|
| Cohort 3 | Experimental | Severe renal impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPX-351 | Drug | CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of CPX-351 | The key PK parameter AUCtau will be assessed | Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start. |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter of the individual components of CPX-351, and their respective metabolites | The key PK parameter AUCtau will be assessed | Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| Northside Hospital - Blood and Bone Marrow Transplant Group of Georgia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38473278 | Derived | Solomon SR, Powell BL, Koprivnikar J, Lai C, Male H, Michaelis LC, Newell LF, Sanford D, Jenkins J, Zelaya A, Coppola S, Faderl S, Walter RB. CPX-351 Pharmacokinetics and Safety in Adults with Hematologic Malignancies and Renal Function Impairment: Phase 1 Trial. Cancers (Basel). 2024 Feb 24;16(5):915. doi: 10.3390/cancers16050915. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2022 | |
| Reset | Mar 15, 2023 |
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| CPX-351 | Drug | CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes. |
|
|
| Incidence of Treatment Emergent Adverse Events (TEAEs) |
TEAEs are defined as any AE starting after the initiation of the first infusion. |
| Up to 31 months. |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| New York Medical/Westchester | Valhalla | New York | 10595 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| University Health Network/Princess Margaret Cancer Center | Toronto | Ontaro | M5G 1Z5 | Canada |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2022 | Mar 15, 2023 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| C000629812 | CPX-351 |
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