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

NCT03187691 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MB-70006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events

  Safety assessments include laboratory tests, vital signs, physical exam and ECG

  35 days

Secondary Outcomes (4)

• Population pharmacokinetic (PK) analysis

  35 days

• Population pharmacokinetic (PK) analysis

  35 days

• Population pharmacokinetic (PK) analysis

  35 days

• Efficacy analysis for time to clinical symptoms of fungal infection

  35 days

Study Arms (3)

CAMB 200 mg

EXPERIMENTAL

200 mg CAMB (MAT2203) Oral Amphotericin B

Drug: Oral Encochleated Amphotericin B (CAMB)

CAMB 400 mg

EXPERIMENTAL

400 mg CAMB (MAT2203) Oral Amphotericin B

Drug: Oral Encochleated Amphotericin B (CAMB)

CAMB 800mg

EXPERIMENTAL

800 mg CAMB (MAT2203) Oral Amphotericin B

Drug: Oral Encochleated Amphotericin B (CAMB)

Interventions

Oral Encochleated Amphotericin B (CAMB) DRUG

Lipid-crystal nano-particle formulation amphotericin B

Also known as: MAT2203

CAMB 200 mg; CAMB 400 mg; CAMB 800mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matinas BioPharma Nanotechnologies, Inc.: lead
• University of Cologne: collaborator
• The Clinical Trials Centre Cologne: collaborator

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Oliver Cornely, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-randomized, open uncontrolled

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 15, 2017
• Study Start: August 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 8, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share