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

Acute Myeloid Leukemia Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT03555955
• Other study ID #: CPX351-102
• Status: Completed
• Phase: Phase 1
• Start date: November 20, 2018
• Est. completion date: May 26, 2021

Study information

• Verified date: July 2021
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Lymphocytic Leukemia
• Acute Myeloid Leukemia
• Hematologic Malignancy
• Hematologic Neoplasms
• Leukemia
• Myelodysplastic Syndromes
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• CPX-351
CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
• CPX-351
CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.

Locations

Country	Name	City	State
Canada	University Health Network/Princess Margaret Cancer Center	Toronto	Ontaro
Canada	Vancouver General Hospital	Vancouver	British Columbia
United States	Northside Hospital - Blood and Bone Marrow Transplant Group of Georgia	Atlanta	Georgia
United States	Baylor University Medical Center	Dallas	Texas
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Weill Cornell Medical College	New York	New York
United States	Oregon Health and Science University	Portland	Oregon
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	New York Medical/Westchester	Valhalla	New York
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PK parameter of the individual components of CPX-351, and their respective metabolites	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	Incidence of Treatment Emergent Adverse Events (TEAEs)	TEAEs are defined as any AE starting after the initiation of the first infusion.	Up to 31 months.