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CompletedNCT03555955Updated Jul 22, 2021

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

A Phase 1 interventional study of CPX-351 and CPX-351 in Hematologic Malignancy, Acute Myeloid Leukemia and Acute Lymphocytic Leukemia, sponsored by Jazz Pharmaceuticals. Completed at 13 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-22.

Sponsored by Jazz Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2021, 5 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hematologic Malignancy
  • Acute Myeloid Leukemia
  • Acute Lymphocytic Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndromes
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 21 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Normal renal function

    Drug: CPX-351

  • Experimental
    Cohort 2

    Moderate renal impairment

    Drug: CPX-351

  • Experimental
    Cohort 3

    Severe renal impairment

    Drug: CPX-351

Interventions

  • DrugCPX-351

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

    Also known as: Vyxeos™

  • DrugCPX-351

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

    Also known as: Vyxeos

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK) of CPX-351

    The key PK parameter AUCtau will be assessed

    Time frame: 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.

Secondary outcomes

  1. PK parameter of the individual components of CPX-351, and their respective metabolites

    The key PK parameter AUCtau will be assessed

    Time frame: 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.

  2. Incidence of Treatment Emergent Adverse Events (TEAEs)

    TEAEs are defined as any AE starting after the initiation of the first infusion.

    Time frame: Up to 31 months.

07

Study locations

13 sites
  • Georgetown University Medical Center
    Washington, District of Columbia 20007, United States
  • Northside Hospital - Blood and Bone Marrow Transplant Group of Georgia
    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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03555955
Lead sponsor
Jazz Pharmaceuticals
Responsible party
Sponsor
First posted
Jun 14, 2018
Start date
Nov 20, 2018
Primary completion
May 26, 2021
Completion
May 26, 2021
Last update
Jul 22, 2021

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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