NCT03555955

A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351

A Phase 1 Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 (Daunorubicin and Cytarabine) Liposome for Injection Treatment in Adult Patients With Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.

Conditions

• Hematologic Malignancy
• Acute Myeloid Leukemia
• Acute Lymphocytic Leukemia
• Acute Lymphoblastic Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	CPX-351	CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
DRUG	CPX-351	CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.

Timeline

• Start date: 2018-11-20
• Primary completion: 2021-05-26
• Completion: 2021-05-26
• First posted: 2018-06-14
• Last updated: 2021-07-22

Locations

13 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study