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CPX-351 Pharmacokinetics and Safety in Adults with Hematologic Malignancies and Renal Function Impairment: Phase 1 Trial.
Solomon, Scott R; Powell, Bayard L; Koprivnikar, Jamie; Lai, Catherine; Male, Heather; Michaelis, Laura C; Newell, Laura F; Sanford, David; Jenkins, Jack; Zelaya, Amy; Coppola, Sheryl; Faderl, Stefan; Walter, Roland B.
Afiliación
  • Solomon SR; Bone & Marrow Transplant (BMT), Leukemia and Cellular Immunotherapy Programs, Northside Hospital Cancer Institute, Atlanta, GA 30342, USA.
  • Powell BL; Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC 27157, USA.
  • Koprivnikar J; John Theurer Cancer Center at Hackensack Meridian Health, Hackensack, NJ 07601, USA.
  • Lai C; Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA 19104, USA.
  • Male H; University of Kansas Cancer Center, Kansas City, KS 66160, USA.
  • Michaelis LC; Division of Hematology/Oncology, Froedtert Hospital, Medical College of Wisconsin, Milwaukee, WI 53226, USA.
  • Newell LF; Knight Cancer Institute, Hematology and Medical Oncology, Oregon Health & Science University, Portland, OR 97239, USA.
  • Sanford D; Leukemia and Bone Marrow Transplant Program of British Columbia, Division of Hematology, Department of Medicine, University of British Columbia, Vancouver, BC V5Z 1M9, Canada.
  • Jenkins J; Jazz Pharmaceuticals, Philadelphia, PA 19103, USA.
  • Zelaya A; Jazz Pharmaceuticals, Philadelphia, PA 19103, USA.
  • Coppola S; Jazz Pharmaceuticals, Philadelphia, PA 19103, USA.
  • Faderl S; Jazz Pharmaceuticals, Palo Alto, CA 94304, USA.
  • Walter RB; Translational Science and Therapeutics Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Cancers (Basel) ; 16(5)2024 Feb 24.
Article en En | MEDLINE | ID: mdl-38473278
ABSTRACT
This open-label phase 1 study (clinicaltrials.gov, NCT03555955) assessed CPX-351 pharmacokinetics (PK) and safety in patients with hematologic malignancies with normal or impaired renal function. Patients were enrolled into three cohorts based on their creatinine clearance (CrCl) ≥90 mL/min (Cohort 1, normal renal function, n = 7), 30 to <59 mL/min (Cohort 2, moderate renal impairment, n = 8), or <30 mL/min (Cohort 3, severe renal impairment, n = 6). Patients received intravenous CPX-351 for initial induction; blood and urine samples were collected for PK analysis. The primary objective was to assess the PK parameters for cytarabine, daunorubicin, and their respective metabolites, arabinosyluracil (Ara-U) and daunorubicinol. Renal impairment did not significantly impact the cytarabine, daunorubicin, or daunorubicinol exposure, but it caused a slight increase in the Ara-U exposure. The CPX-351 side effect profile was similar in patients with impaired renal function compared to those with normal renal function. All the patients reported ≥1 treatment-emergent adverse event (TEAE), most commonly febrile neutropenia and nausea (57% each) and hyperglycemia (43%); no patients discontinued treatment due to TEAEs. These data suggest that CPX-351 dose adjustment is not required for patients with hematologic malignancies with moderate or severe renal impairment.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Cancers (Basel) Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Cancers (Basel) Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza