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CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis (CAMB)

This study is currently recruiting participants.
Verified December 2017 by Matinas BioPharma Nanotechnologies, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02629419
First Posted: December 14, 2015
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Matinas BioPharma Nanotechnologies, Inc.
  Purpose
This is an open-label, dose-titration trial to study the efficacy, safety, and pharmacokinetics of oral cochleate amphotericin B (CAMB) in the treatment of mucocutaneous candidiasis infections in patients who are refractory or intolerant to standard non intravenous therapies.

Condition Intervention Phase
Candidiasis, Chronic Mucocutaneous Drug: Amphotericin B Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a Efficacy, Safety, Tolerability, and PK Study of Encochleated Amphotericin B (CAMB/MAT2203) in Patients With Mucocutaneous Candidiasis Who Are Refractory or Intolerant to Standard Non-Intravenous Therapies

Resource links provided by NLM:


Further study details as provided by Matinas BioPharma Nanotechnologies, Inc.:

Primary Outcome Measures:
  • Symptoms of mucocutaneous candidiasis [ Time Frame: 14-days at highest titrated dose ]
    dysphagia, odynophagia, retrosternal pain, oral pain, burning of mouth or vaginal erythema, vulvovaginal pruritus, vaginal discharge


Secondary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: Single and Multiple Dose (14-days) ]
    Drug concentrations in plasma, urine and saliva

  • Peak Plasma Concentration (Cmax) [ Time Frame: Single and Multiple Dose (14-days) ]
  • Adverse events, changes in laboratory parameters [ Time Frame: up to 54 days ]

Other Outcome Measures:
  • Long-term adverse events, changes in laboratory parameters [ Time Frame: up to 6-months ]
  • Long-term symptoms of mucocutaneous candidiasis [ Time Frame: up to 6-months ]
    dysphagia, odynophagia, retrosternal pain, oral pain, burning of mouth or vaginal erythema, vulvovaginal pruritus, vaginal discharge


Estimated Enrollment: 16
Study Start Date: November 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAMB (Encochleated Amphotericin B)
Encochleated Amphotericin B (200 mg, 400 mg, 800 mg)
Drug: Amphotericin B
Lipid crystal nano-particle formulation of amphotericin B
Other Names:
  • Encochleated Amphotericin B
  • CAMB
  • MAT2203

Detailed Description:
Patients aged 18 to 75 years with mucocutaneous candidiasis (esophageal, oropharyngeal, or vulvovaginal) who are refractory or intolerant to standard non-intravenous therapies will be enrolled. Patients will initially be treated in a short-term dose titration period, where the dose may be increased in patients that do not respond clinically. Patients who do not respond clinically to the highest dose of drug will discontinue the protocol. Patients that respond to treatment and tolerate the study medication will be eligible to enter a long-term extension (up to 6-months).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a clinical diagnosis of at least one of the following:
  • Persistent OPC for greater than 2 weeks documented on at least one occasion by KOH or fungal stain and confirmed by mycological culture to be azole resistant within the previous 6 months and/or intolerance to standard non intravenous therapies.
  • EC associated with clinical symptoms of retrosternal pain, odynophagia, and/or pain with swallowing and documented by esophageal biopsy or visualization with culture documenting azole resistance within the previous 6 months and/or intolerance to standard non-intravenous therapies.
  • Persistent VVC for greater than 2 weeks as documented by presence of vaginal symptoms and a positive wet mount showing Candida structures and confirmed by a vaginal culture positive for Candida with azole resistance within the previous 6 months and/or intolerance to standard non intravenous therapies.
  • Patient is expected to survive for > = 6 months.
  • Willing to have samples stored for future research.
  • Agree to use highly effective contraception.

    • Contraception: Because the effects of CAMB on the developing human fetus are unknown, sexually active patients of childbearing potential must agree to use highly effective contraception as outlined below before study entry and for the duration of study participation. Females of childbearing potential must have a negative pregnancy test result before receiving CAMB. During the course of the study, if a patient becomes pregnant or suspects they are pregnant, then they should inform the study staff and their primary care physician immediately. Acceptable forms of contraception are:

      • Intrauterine device (IUD) or equivalent.
      • Hormonal contraceptives (eg, consistent, timely and continuous use of contraceptive pill, patch, ring, implant, or injection that has reached full efficacy prior to dosing). If the patient uses contraceptive pill, patch, or ring, then a barrier method (eg, male/female condom, cap, or diaphragm plus spermicide) must also be used at the time of potentially reproductive sexual activity.
      • Be in a stable, long-term monogamous relationship, per PI assessment, with a partner that does not pose any potential pregnancy risk, eg, has undergone a vasectomy at least 6 months prior to first dose of study agent or is of the same sex as the patient.
      • Have had a hysterectomy and/or a bilateral tubal ligation or both ovaries removed.

Exclusion Criteria:

  • Allergy to any AMB product or any component of CAMB (eg, phosphatidylserine)
  • Have evidence of systemic fungal infections requiring intravenous antifungal therapy
  • Pregnant or nursing women, and women intending to become pregnant during the study period
  • Had a concomitant medical condition that could interfere with study drug evaluation or that is a contraindication to the proposed investigational treatment based upon known agent safety profile or toxicities.
  • Had any of the following laboratory abnormalities at the screening visit:

    • Alanine Transaminase (ALT), Aspartate Transaminase (AST) and Alkaline phosphatase (ALP) > 2.5 times the upper limit of normal (ULN).
    • Total bilirubin level > 2.5 times the ULN
    • Serum creatinine level > 2 times the ULN
    • Absolute neutrophil count less than 500 cells/microliter
    • Potassium level less than or equal to 3.5 mmol/L
  • Exposure to any investigational agent within 4 weeks prior to Day 0 (Baseline).
  • Current or recent history (past 12 months) of drug or alcohol abuse.
  • Use of intravenous AMB products within 1-week of start of study drug administration
  • Use of non-intravenous AMB products (such as oral AMB swishes) within 72 hours prior to start of study drug administration
  • Subjects receiving potassium supplements.
  • Any other condition the investigator believes would interfere with the patient s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629419


Contacts
Contact: Alexandra Freeman, MD freemaal@mail.nih.gov

Locations
United States, Maryland
National Institute of Allergy and Infectious Disease (NIAID) Recruiting
Bethesda, Maryland, United States, 20892
Contact: Alexandra Freeman, MD       freemaal@mail.nih.gov   
Principal Investigator: Alexandra Freeman, MD         
Sub-Investigator: Michail S. Lionakis, MD, ScD         
Sponsors and Collaborators
Matinas BioPharma Nanotechnologies, Inc.
Investigators
Principal Investigator: Alexandra Freeman, MD National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Responsible Party: Matinas BioPharma Nanotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT02629419     History of Changes
Other Study ID Numbers: MB-70004
16-I-0002 ( Other Identifier: NIAID )
First Submitted: November 16, 2015
First Posted: December 14, 2015
Last Update Posted: December 7, 2017
Last Verified: December 2017

Keywords provided by Matinas BioPharma Nanotechnologies, Inc.:
STAT3 deficient Hyper IgE syndrome
Gain of function STAT1 defects
Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy (APECED)
IL-17/IL-22 autoantibodies from thymoma
Job's Syndrome (Hyperimmunoglobulin E Syndrome, Buckley Syndrome)

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Chronic Mucocutaneous
Mycoses
Dermatomycoses
Skin Diseases, Infectious
Infection
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents