A Phase 2 interventional study of Amphotericin B in Candidiasis, Chronic Mucocutaneous, sponsored by Matinas BioPharma Nanotechnologies, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Matinas BioPharma Nanotechnologies, Inc. · Phase 2, Interventional, and Treatment
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.
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 60-months).
Matinas BioPharma Nanotechnologies, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Agree to use highly effective .
Contraception: Because the effects of CAMB on the developing human fetus are unknown, sexually active patients of 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:
Exclusion Criteria:
Had any of the following laboratory abnormalities at the screening visit:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Encochleated Amphotericin B (200 mg, 400 mg, 800 mg)
Drug: Amphotericin B
Oral lipid nanocrystal formulation of amphotericin B
Also known as: Encochleated Amphotericin B, CAMB, MAT2203
Clinical Response to Treatment of Mucocutaneous Candidiasis
Number of subjects with a clinical response of clinical cure or improvement. Clinical cure was defined as absence of signs or symptoms of infection. Clinical improvement was defined as follows: * OPC or EC: partial resolution defined as greater than or equal to 50% of Baseline signs or symptoms * VVC: reduction of greater than or equal to 50% of clinical severity score from Baseline Severity of each symptom was graded on a scale from zero (absence of symptoms) to 3 (severe symptoms). The sum of all scores for all symptoms was used as the clinical severity score. Higher scores mean worse outcomes.
Time frame: 14-days at highest titrated dose
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Postdose
Drug concentration in plasma collected at 0, 1, 2, 4, 8, 10, 12, and 24 hours post-dose
Time frame: Single and Multiple Doses (14-days)
Maximum Plasma Concentration (Cmax)
Plasma concentration was measured at 0, 1, 2, 4, 8, 10, 12, and 24 hours post-dose
Time frame: Single and Multiple Doses (14-days)
Time to Reach Maximum Plasma Concentration (Tmax)
Plasma collected at 0, 1, 2, 4, 8, 10, 12, and 24 hours post-dose
Time frame: Single and Multiple Doses (14-days)
Long-term Adverse Events, Changes in Laboratory Parameters
Incidence of nephrotoxicity, defined as an increase of greater than 100% of baseline serum creatinine. Incidence of hypokalemia, defined as serum potassium less than or equal to 3mmol/L during or within 3 weeks of completing treatment.
Time frame: up to 60 months
| Milestone | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
Number of subjects with a clinical response of clinical cure or improvement. Clinical cure was defined as absence of signs or symptoms of infection. Clinical improvement was defined as follows: * OPC or EC: partial resolution defined as greater than or equal to 50% of Baseline signs or symptoms * VVC: reduction of greater than or equal to 50% of clinical severity score from Baseline Severity of each symptom was graded on a scale from zero (absence of symptoms) to 3 (severe symptoms). The sum of all scores for all symptoms was used as the clinical severity score. Higher scores mean worse outcomes.
| Participants | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| Clinical Response to Treatment of Mucocutaneous Candidiasis | 4 |
Drug concentration in plasma collected at 0, 1, 2, 4, 8, 10, 12, and 24 hours post-dose
| ng x h/mL | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Postdose | 606 (435.18 to 777.17) |
Plasma concentration was measured at 0, 1, 2, 4, 8, 10, 12, and 24 hours post-dose
| ng/mL | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| Maximum Plasma Concentration (Cmax) | 28.4 (27.02 to 52.60) |
Plasma collected at 0, 1, 2, 4, 8, 10, 12, and 24 hours post-dose
| h | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) | 16 (4 to 24) |
Incidence of nephrotoxicity, defined as an increase of greater than 100% of baseline serum creatinine. Incidence of hypokalemia, defined as serum potassium less than or equal to 3mmol/L during or within 3 weeks of completing treatment.
| events | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| Long-term Adverse Events, Changes in Laboratory Parameters | 0 |
Collected over Adverse events were collected over the entire study period up to 60 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) | 0/4 (0%) | 3/4 (75%) | 4/4 (100%) |
| Event | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| PneumoniaInfections and infestations | 2/4 |
| Colostomy closureSurgical and medical procedures | 1/4 |
| InfluenzaGeneral disorders | 1/4 |
| MyositisMusculoskeletal and connective tissue disorders | 1/4 |
| Adrenal insufficiencyEndocrine disorders | 1/4 |
| DysphagiaGastrointestinal disorders | 1/4 |
| Oral candidiasisInfections and infestations | 1/4 |
| Urinary tract infectionInfections and infestations | 1/4 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/4 |
| Subcutaneous abscessInfections and infestations | 1/4 |
| Event | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| HyperglycaemiaMetabolism and nutrition disorders | 4/4 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/4 |
| DiarrhoeaGastrointestinal disorders | 3/4 |
| NauseaGastrointestinal disorders | 3/4 |
| FatigueGeneral disorders | 3/4 |
| PneumoniaInfections and infestations | 3/4 |
| C-reactive protein increasedInvestigations | 3/4 |
| White blood cell count increasedInvestigations | 3/4 |
| HypocalcaemiaMetabolism and nutrition disorders | 3/4 |
| HeadacheNervous system disorders | 3/4 |
| Age, Categorical(Participants) | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| Female | 4 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| United States | 4 |
| Chronic Mucocutaneous Candidiasis (CMC) Infection Type(participants) | MAT2203 (Previously Referred to as Encochleated Oral Amphotericin B [CAMB]) |
|---|---|
| Oropharyngeal candidiasis (OPC) | 3 |
| Esophageal candidiasis (EC) | 1 |
| Vulvovaginal candidiasis (VVC) | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amphotericin B
Candidiasis, Chronic Mucocutaneous
Matinas BioPharma Nanotechnologies, Inc.