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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 : Recruiting
First Posted : June 14, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE May 14, 2018
First Posted Date  ICMJE June 14, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE November 20, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03555955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351
Official Title  ICMJE 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
Brief Summary This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hematologic Malignancy
  • Acute Myeloid Leukemia
  • Acute Lymphocytic Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndromes
Intervention  ICMJE
  • Drug: CPX-351
    CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
    Other Name: Vyxeos™
  • Drug: CPX-351
    CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
    Other Name: Vyxeos
Study Arms  ICMJE
  • Experimental: Cohort 1
    Normal renal function
    Intervention: Drug: CPX-351
  • Experimental: Cohort 2
    Moderate renal impairment
    Intervention: Drug: CPX-351
  • Experimental: Cohort 3
    Severe renal impairment
    Intervention: Drug: CPX-351
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2018)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Director Clinical Trial Disclosure 2158323750 ClinicalTrialDisclosure@JazzPharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03555955
Other Study ID Numbers  ICMJE CPX351-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jazz Pharmaceuticals
Study Sponsor  ICMJE Jazz Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jazz Pharmaceuticals
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP