Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Ability to understand and voluntarily give informed consent. 2. Male or female patients, age ≥18 years at the time of consent. 3. 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. 4. Patients with normal renal function, or moderate or severe renal impairment as categorized by creatinine clearance (CrCl)) using the Cockcroft-Gault Formula. 5. 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. 6. 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.

Exclusion Criteria

  1. Prior treatment with CPX-351 ≤ to 1 month before the start of CPX-351 in this study. 2. Patients with active (uncontrolled, metastatic) second malignancies are excluded. 3. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent obtaining informed consent. 4. Patients with known hypersensitivity to cytarabine, daunorubicin, or liposomal products. 5. Female patients who are pregnant, nursing, or lactating. 6. 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. 7. Any other condition that would cause a risk to patients if they participate in the trial.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1
Normal renal function
  • Drug: CPX-351
    CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
    Other names:
    • Vyxeos™
Experimental
Cohort 2
Moderate renal impairment
  • Drug: CPX-351
    CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
    Other names:
    • Vyxeos
Experimental
Cohort 3
Severe renal impairment
  • Drug: CPX-351
    CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
    Other names:
    • Vyxeos

More Details

Status
Completed
Sponsor
Jazz Pharmaceuticals

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.