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

Completed · Phase 1

Conditions studied: Hematologic Malignancy, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes

In brief

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

Key facts

Study ID

NCT03555955

Run by

Jazz Pharmaceuticals

People needed

21

Starts

2018-11-20

Expected to finish

2021-05-26

Last updated by the study team

2021-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand and voluntarily give informed consent.
• Male or female patients, age ≥18 years at the time of consent.
• Diagnosis of hematologic malignancy including, but not limited to, AML, ALL, and MDS. Patients may be newly diagnosed, refractory to initial treatment, or in relapse.
• Patients with normal renal function, or moderate or severe renal impairment as categorized by creatinine clearance (CrCl)) using the Cockcroft-Gault Formula.
• Consent of female patients to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351.
• Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351.

You may not qualify if…

• Prior treatment with CPX-351 ≤ to 1 month before the start of CPX-351 in this study.
• Patients with active (uncontrolled, metastatic) second malignancies are excluded.
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent obtaining informed consent.
• Patients with known hypersensitivity to cytarabine, daunorubicin, or liposomal products.
• Female patients who are pregnant, nursing, or lactating.
• Participation in another clinical trial of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to enrollment in this study.
• Any other condition that would cause a risk to patients if they participate in the trial.

Where it is running

• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Northside Hospital - Blood and Bone Marrow Transplant Group of Georgia — Atlanta, Georgia, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Weill Cornell Medical College — New York, New York, United States
• New York Medical/Westchester — Valhalla, New York, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• University Health Network/Princess Margaret Cancer Center — Toronto, Ontaro, Canada

Full record on ClinicalTrials.gov

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