Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02629419
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2015-11-16
Brief Title:
CAMBMAT2203 in Patients With Mucocutaneous Candidiasis
Sponsor:
Matinas BioPharma Nanotechnologies Inc
Organization:
Matinas BioPharma Nanotechnologies Inc
Study Overview
Official Title:
A Phase 2a Efficacy Safety Tolerability and PK Study of Encochleated Amphotericin B CAMBMAT2203 in Patients With Mucocutaneous Candidiasis Who Are Refractory or Intolerant to Standard Non-Intravenous Therapies
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMB
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 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 60-months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 16-I-0002 | OTHER | NIAID | None |