Clinical Trials /

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

NCT03555955

Description:

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

Related Conditions:
  • Leukemia
  • Malignant Bone Marrow Neoplasm
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CPX351-102
  • NCT ID: NCT03555955

Conditions

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

Interventions

DrugSynonymsArms
CPX-351VyxeosCohort 1
CPX-351VyxeosCohort 2

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Cohort 1ExperimentalNormal renal function
  • CPX-351
Cohort 2ExperimentalModerate renal impairment
  • CPX-351
Cohort 3ExperimentalSevere renal impairment
  • CPX-351

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pharmacokinetics (PK) of CPX-351
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.
Safety Issue:
Description:The key PK parameter AUCtau will be assessed

Secondary Outcome Measures

Measure:PK parameter of the individual components of CPX-351, and their respective metabolites
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.
Safety Issue:
Description:The key PK parameter AUCtau will be assessed
Measure:Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame:Up to 31 months.
Safety Issue:
Description:TEAEs are defined as any AE starting after the initiation of the first infusion.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jazz Pharmaceuticals

Last Updated

July 9, 2020