Description:
This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or
severe renal impairment.
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
Drug | Synonyms | Arms |
---|
CPX-351 | Vyxeos™ | Cohort 1 |
CPX-351 | Vyxeos | Cohort 2 |
Purpose
This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or
severe renal impairment.
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort 1 | Experimental | Normal renal function | |
Cohort 2 | Experimental | Moderate renal impairment | |
Cohort 3 | Experimental | Severe renal impairment | |
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: | Completed |
Lead Sponsor: | Jazz Pharmaceuticals |
Last Updated
July 22, 2021