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
1 other identifier
interventional
21
2 countries
13
Brief Summary
This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2018
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2018
CompletedFirst Posted
Study publicly available on registry
June 14, 2018
CompletedStudy Start
First participant enrolled
November 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2021
CompletedJuly 22, 2021
July 1, 2021
2.5 years
May 14, 2018
July 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics (PK) of CPX-351
The key PK parameter AUCtau will be assessed
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 (2)
PK parameter of the individual components of CPX-351, and their respective metabolites
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.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Up to 31 months.
Study Arms (3)
Cohort 1
EXPERIMENTALNormal renal function
Cohort 2
EXPERIMENTALModerate renal impairment
Cohort 3
EXPERIMENTALSevere renal impairment
Interventions
CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Georgetown University Medical Center
Washington D.C., 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
Related Publications (1)
Solomon SR, Powell BL, Koprivnikar J, Lai C, Male H, Michaelis LC, Newell LF, Sanford D, Jenkins J, Zelaya A, Coppola S, Faderl S, Walter RB. CPX-351 Pharmacokinetics and Safety in Adults with Hematologic Malignancies and Renal Function Impairment: Phase 1 Trial. Cancers (Basel). 2024 Feb 24;16(5):915. doi: 10.3390/cancers16050915.
PMID: 38473278DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2018
First Posted
June 14, 2018
Study Start
November 20, 2018
Primary Completion
May 26, 2021
Study Completion
May 26, 2021
Last Updated
July 22, 2021
Record last verified: 2021-07