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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer
Therapuetic Areas:Nephrology / Urology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:November 20, 2018
End Date:March 2021
Contact:Director Clinical Trial Disclosure
Email:ClinicalTrialDisclosure@JazzPharma.com
Phone:2158323750

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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

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


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.
We found this trial at
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Westwood, Kansas 66205
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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1 Medical Center Drive
Morgantown, West Virginia 26506
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