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

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ClinicalTrials.gov Identifier: NCT03555955
Recruitment Status : Not yet recruiting
First Posted : June 14, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Acute Myeloid Leukemia Acute Lymphocytic Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Drug: CPX-351 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: Cohort 1
Normal renal function
Drug: CPX-351
CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
Other Name: Vyxeos™

Experimental: Cohort 2
Moderate renal impairment
Drug: CPX-351
CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
Other Name: Vyxeos

Experimental: Cohort 3
Severe renal impairment
Drug: CPX-351
CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
Other Name: Vyxeos




Primary Outcome Measures :
  1. 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. ]
    The key PK parameter AUCtau will be assessed


Secondary Outcome Measures :
  1. 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. ]
    The key PK parameter AUCtau will be assessed

  2. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 31 months. ]
    TEAEs are defined as any AE starting after the initiation of the first infusion.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555955


Contacts
Contact: Associate Director Clinical Trial Disclosure 2158323750 ClinicalTrialDisclosure@JazzPharma.com

Sponsors and Collaborators
Jazz Pharmaceuticals

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03555955     History of Changes
Other Study ID Numbers: CPX351-102
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Neoplasms
Myelodysplastic Syndromes
Preleukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Renal Insufficiency
Neoplasms by Histologic Type
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Kidney Diseases
Urologic Diseases