Clinical Trial: CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Into

Brief Summary: 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.

Detailed Summary: 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).
Sponsor: Matinas BioPharma Nanotechnologies, Inc.

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Matinas BioPharma Nanotechnologies, Inc.

Dates:
Date Received: November 16, 2015
Date Started: November 2015
Date Completion: June 2017
Last Updated: April 18, 2017
Last Verified: April 2017