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

Sponsor
Jazz Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03555955
Collaborator
(none)
21
Enrollment
13
Locations
3
Arms
30.2
Actual Duration (Months)
1.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
21 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
Actual Study Start Date :
Nov 20, 2018
Actual Primary Completion Date :
May 26, 2021
Actual Study Completion Date :
May 26, 2021

Arms and Interventions

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 Names:
  • Vyxeos™

    		•
    Experimental: Cohort 2

    Moderate renal impairment

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

    		•
    Experimental: Cohort 3

    Severe renal impairment

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK) of CPX-351 [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 [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) [Up to 31 months.]

      TEAEs are defined as any AE starting after the initiation of the first infusion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Georgetown University Medical Center Washington District of Columbia United States 20007
    2 Northside Hospital - Blood and Bone Marrow Transplant Group of Georgia Atlanta Georgia United States 30342
    3 University of Kansas Cancer Center Westwood Kansas United States 66205
    4 Hackensack University Medical Center Hackensack New Jersey United States 07601
    5 Weill Cornell Medical College New York New York United States 10021
    6 New York Medical/Westchester Valhalla New York United States 10595
    7 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157
    8 Oregon Health and Science University Portland Oregon United States 97239
    9 Baylor University Medical Center Dallas Texas United States 75246
    10 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    11 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    12 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
    13 University Health Network/Princess Margaret Cancer Center Toronto Ontaro Canada M5G 1Z5

    Sponsors and Collaborators

    • Jazz Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jazz Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03555955
    Other Study ID Numbers:
    • CPX351-102
    First Posted:
    Jun 14, 2018
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Neoplasms
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Hematologic Neoplasms
    Myelodysplastic Syndromes

    Study Results

    No Results Posted as of Jul 22, 2021