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

Phase 2

Withdrawn

• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia
• Interventions: Drug: Oral Encochleated Amphotericin B (CAMB)

• Registration Number: NCT03187691
• Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.

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.

Study Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-15
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08
• Study Start: 2019-08
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAMB 200 mg	Oral Encochleated Amphotericin B (CAMB)	200 mg CAMB (MAT2203) Oral Amphotericin B
CAMB 400 mg	Oral Encochleated Amphotericin B (CAMB)	400 mg CAMB (MAT2203) Oral Amphotericin B
CAMB 800mg	Oral Encochleated Amphotericin B (CAMB)	800 mg CAMB (MAT2203) Oral Amphotericin B

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	35 days	Safety assessments include laboratory tests, vital signs, physical exam and ECG

Secondary Outcome Measures

Name	Time	Method
Efficacy analysis for time to clinical symptoms of fungal infection	35 days	Clinical symptoms of fungal infections include evaluation of respiratory symptoms, sinuses, skin.
Population pharmacokinetic (PK) analysis	35 days	PK parameter for Area under the plasma concentration time curve (AUC)