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

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Hematologic Malignancy; Acute Lymphocytic Leukemia; Myelodysplastic Syndromes
• Interventions: Drug: CPX-351

• Registration Number: NCT03555955
• Lead Sponsor: Jazz Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-14
• Study Start: 2018-11-20
• Primary Completion: 2021-05-26
• Study Completion: 2021-05-26
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	CPX-351	Normal renal function
Cohort 2	CPX-351	Moderate renal impairment
Cohort 3	CPX-351	Severe renal impairment

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of CPX-351	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.	The key PK parameter AUCtau will be assessed

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events (TEAEs)	Up to 31 months.	TEAEs are defined as any AE starting after the initiation of the first infusion.
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.	The key PK parameter AUCtau will be assessed

Trial Locations

Locations (13)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Northside Hospital - Blood and Bone Marrow Transplant Group of Georgia; 🇺🇸 Atlanta, Georgia, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States

New York Medical/Westchester; 🇺🇸 Valhalla, New York, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States

University Health Network/Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontaro, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States