search
Back to results

Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia

Primary Purpose

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Oral Encochleated Amphotericin B (CAMB)
Sponsored by
Matinas BioPharma Nanotechnologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed AML/ALL receiving chemotherapy inducing neutropenia < 500 cells/mm3
  • Able to have all screening tests done to allow for study drug administration no later than 5 days after start of chemotherapy
  • Sign informed consent
  • ≥ 18 years of age

Exclusion Criteria:

  • Known hypersensitivity to amphotericin B, specifically anaphylactic reaction
  • Fungal induced fever (≥ 38°C)
  • Proven, possible or probably invasive fungal infection in previous 12 months
  • Serum galactomannan index (GMI)≥ 0.5 at screening
  • Pulmonary infiltrates at screening
  • Current treatment with amphotericin B
  • Sever comorbidity other than underlying haematological disease
  • Prolongation of corrected QT interval
  • History of convulsion
  • Pregnant or breastfeeding
  • Females of childbearing potential who do not practice sexual abstinence or who do not agree to use appropriate contraceptive methods
  • Presence of hepatic disease
  • Total bilirubin > 3 x upper limit of normal
  • Age-adjusted creatinine clearance < 30 mL/minute
  • Participating in any other clinical study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    CAMB 200 mg

    CAMB 400 mg

    CAMB 800mg

    Arm Description

    200 mg CAMB (MAT2203) Oral Amphotericin B

    400 mg CAMB (MAT2203) Oral Amphotericin B

    800 mg CAMB (MAT2203) Oral Amphotericin B

    Outcomes

    Primary Outcome Measures

    Incidence of treatment emergent adverse events
    Safety assessments include laboratory tests, vital signs, physical exam and ECG

    Secondary Outcome Measures

    Population pharmacokinetic (PK) analysis
    PK parameter for Time to maximum concentration (Tmax)
    Population pharmacokinetic (PK) analysis
    PK parameter for Peak plasma concentration (Cmax)
    Population pharmacokinetic (PK) analysis
    PK parameter for Area under the plasma concentration time curve (AUC)
    Efficacy analysis for time to clinical symptoms of fungal infection
    Clinical symptoms of fungal infections include evaluation of respiratory symptoms, sinuses, skin.

    Full Information

    First Posted
    May 31, 2017
    Last Updated
    March 6, 2019
    Sponsor
    Matinas BioPharma Nanotechnologies, Inc.
    Collaborators
    University of Cologne, The Clinical Trials Centre Cologne
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03187691
    Brief Title
    Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia
    Official Title
    An Open Label Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous (AML) and Lymphoblastic Leukaemia (ALL)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Protocol redundancy
    Study Start Date
    August 2019 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Matinas BioPharma Nanotechnologies, Inc.
    Collaborators
    University of Cologne, The Clinical Trials Centre Cologne

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)
    Detailed Description
    This is an open label phase II clinical study to evaluate the safety and pharmacokinetics of oral encochleated Amphotericin B (CAMB/MAT2203) for prevention of invasive fungal infections in approximately 30 patients undergoing induction therapy for AML/ALL.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Non-randomized, open uncontrolled
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CAMB 200 mg
    Arm Type
    Experimental
    Arm Description
    200 mg CAMB (MAT2203) Oral Amphotericin B
    Arm Title
    CAMB 400 mg
    Arm Type
    Experimental
    Arm Description
    400 mg CAMB (MAT2203) Oral Amphotericin B
    Arm Title
    CAMB 800mg
    Arm Type
    Experimental
    Arm Description
    800 mg CAMB (MAT2203) Oral Amphotericin B
    Intervention Type
    Drug
    Intervention Name(s)
    Oral Encochleated Amphotericin B (CAMB)
    Other Intervention Name(s)
    MAT2203
    Intervention Description
    Lipid-crystal nano-particle formulation amphotericin B
    Primary Outcome Measure Information:
    Title
    Incidence of treatment emergent adverse events
    Description
    Safety assessments include laboratory tests, vital signs, physical exam and ECG
    Time Frame
    35 days
    Secondary Outcome Measure Information:
    Title
    Population pharmacokinetic (PK) analysis
    Description
    PK parameter for Time to maximum concentration (Tmax)
    Time Frame
    35 days
    Title
    Population pharmacokinetic (PK) analysis
    Description
    PK parameter for Peak plasma concentration (Cmax)
    Time Frame
    35 days
    Title
    Population pharmacokinetic (PK) analysis
    Description
    PK parameter for Area under the plasma concentration time curve (AUC)
    Time Frame
    35 days
    Title
    Efficacy analysis for time to clinical symptoms of fungal infection
    Description
    Clinical symptoms of fungal infections include evaluation of respiratory symptoms, sinuses, skin.
    Time Frame
    35 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Newly diagnosed AML/ALL receiving chemotherapy inducing neutropenia < 500 cells/mm3 Able to have all screening tests done to allow for study drug administration no later than 5 days after start of chemotherapy Sign informed consent ≥ 18 years of age Exclusion Criteria: Known hypersensitivity to amphotericin B, specifically anaphylactic reaction Fungal induced fever (≥ 38°C) Proven, possible or probably invasive fungal infection in previous 12 months Serum galactomannan index (GMI)≥ 0.5 at screening Pulmonary infiltrates at screening Current treatment with amphotericin B Sever comorbidity other than underlying haematological disease Prolongation of corrected QT interval History of convulsion Pregnant or breastfeeding Females of childbearing potential who do not practice sexual abstinence or who do not agree to use appropriate contraceptive methods Presence of hepatic disease Total bilirubin > 3 x upper limit of normal Age-adjusted creatinine clearance < 30 mL/minute Participating in any other clinical study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Oliver Cornely, MD
    Organizational Affiliation
    University of Cologne
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia

    We'll reach out to this number within 24 hrs