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

Jazz Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hematologic Malignancy; Acute Lymphocytic Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndromes; Acute Myeloid Leukemia

Treatments: Drug: CPX-351

Study type: Interventional

Funder types: Industry

Identifiers

NCT03555955

CPX351-102

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Normal renal function

Treatment:

Drug: CPX-351

Drug: CPX-351

Cohort 2

Experimental group

Description:

Moderate renal impairment

Treatment:

Drug: CPX-351

Drug: CPX-351

Cohort 3

Experimental group

Description:

Severe renal impairment

Treatment:

Drug: CPX-351

Drug: CPX-351