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An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris (APEX)

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.
 
ClinicalTrials.gov Identifier: NCT04148287
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Amplyx Pharmaceuticals

Brief Summary:
This is a multicenter, open-label, single arm study to evaluate the efficacy and safety of APX001 for the treatment of candidemia and/or invasive candidiasis caused by C. auris in patients aged 18 years and over with limited antifungal treatment options.

Condition or disease Intervention/treatment Phase
Candidemia Invasive Candidiases Candida Infection Drug: APX001 Phase 2

Detailed Description:
This is a multicenter, open-label, non-comparative, single arm study to evaluate the efficacy and safety of APX001 for the treatment of candidemia and/or invasive candidiasis caused by C. auris in patients aged 18 years and over with limited antifungal treatment options. The Study Drug Treatment Period will be up to a maximum of 42 days (inclusive of the loading dose [Study Day 1]). There will be a Follow up Period of 4 weeks (+4 days) after EOST. The total duration of participation in the study is up to approximately 10.5 weeks (inclusive of the Screening Period [168 hours prior to Baseline]).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single arm intervention. All patients will receive APX001. On Days 1-3, APX001 will be administered intravenously. Thereafter, if the patient is able to take oral medication, APX001 tablets will be taken orally.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Patients With Candidemia and/or Invasive Candidiasis Caused by Candida Auris
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: APX001
APX001 IV or oral for up to 42 days
Drug: APX001
Day 1: APX001 1000 mg IV BID over a 3-hour infusion Days 2-3: APX001 600 mg IV QD over a 3-hour infusion Days 4 - 42: APX001 600 mg IV QD over a 3-hour infusion or APX001 800 mg QD oral.




Primary Outcome Measures :
  1. Treatment Success [ Time Frame: Up to 42 days ]
    The primary efficacy parameter is percentage of patients with Treatment Success at end of study treatment as determined by the Data Review Committee (DRC).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Limited or no treatment options due to resistance, contraindication, intolerance or lack of clinical response to standard of care antifungal therapy, as advocated by the relevant regional/country treatment guidelines
  • Established mycological and clinical diagnosis of candidemia and/or invasive candidiasis caused by Candida auris
  • Able to have pre-existing intravascular catheters removed and replaced (if necessary)
  • Females of childbearing potential with male partners, and males with female partner(s) of childbearing potential, must agree to use 2 forms of highly effective contraception throughout the duration of the study and for 90 days following the last study drug administration. Females of childbearing potential must have a negative urine pregnancy test within 96 hours prior study entry.
  • Wiling to participate in the study, willing to give written informed consent, and willing to comply with the study restrictions; where permitted by local regulations, written informed consent from a legal authorized representative (LAR) will be obtained for patients who are unable to give consent

Exclusion Criteria:

  • Life expectancy of less than 7 days in the opinion of the Investigator
  • Human immunodeficiency virus-infected patients who are receiving antiretroviral therapy that are moderate to strong inducers of CYP3A4, or who have detectable viremia, or who have had an active opportunistic infection within 6 months prior
  • Alanine aminotransferase or aspartate aminotransferase greater than or equal to 5 times the upper limit of normal
  • Total bilirubin greater than 3 time the upper limit of normal, unless isolated hyperbilirubinemia or due to documented Gilbert's disease
  • Pregnant or lactating female patient
  • Inappropriate fungal infection source control
  • Investigational drug administered within 30 days prior to dosing or five half-lives whichever is longer
  • Diagnosis of deep-seated Candida-related infections causing hardware associated septic arthritis, osteomyelitis, endocarditis, myocarditis, hepatosplenic candidiasis, or a central nervous system infection or site of infection that would require antifungal therapy to exceed the maximal duration of study drug treatment

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): NCT04148287


Locations
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Panama
Clinical Trial Site Not yet recruiting
Panama City, Panama
Contact: Eric Ople    858 345 1755    eople@amplyx.com   
South Africa
Clinical Trial Site Recruiting
Johannesburg, South Africa
Contact: Eric Ople    858 345 1755    eople@amplyx.com   
Principal Investigator: Amplyx Pharmaceuticals         
Clinical Trial Site Recruiting
Pretoria, South Africa
Contact: Eric Ople    858 345 1755    eople@amplyx.com   
Contact: Amplyx Pharmaceuticals         
Sponsors and Collaborators
Amplyx Pharmaceuticals
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Responsible Party: Amplyx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04148287    
Other Study ID Numbers: APX001-203
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared in a manuscript. All IPD will be anonymized. IPD will include summarized efficacy, safety and pharmacokinetics data
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Approximately 6 months following the last patient's last visit in the study.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes