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Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds (AEGIS)

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: NCT04240886
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Amplyx Pharmaceuticals

Study Description
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Brief Summary:
This is a Phase 2, multicenter study to evaluate APX001 for the treatment of invasive fungal infections caused by Aspergillus spp. or rare molds (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi).

Condition or disease Intervention/treatment Phase
Invasive Fungal Infections Drug: fosmanogepix Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of APX001 in the Treatment of Patients With Invasive Mold Infections Caused by Aspergillus Species or Rare Molds
Actual Study Start Date : January 4, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A: fosmanogepix (APX001) Drug: fosmanogepix
IV and oral fosmanogepix
Other Names:
  • APX001
  • E210
Experimental: Cohort B: fosmanogepix (APX001) Drug: fosmanogepix
IV and oral fosmanogepix
Other Names:
  • APX001
  • E210


Outcome Measures
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Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: Day 42 ]

Secondary Outcome Measures :
  1. Global Response [ Time Frame: End of Study Treatment or Day 42 ]

Other Outcome Measures:
  1. All-Cause Mortality [ Time Frame: Day 84 ]

Eligibility Criteria
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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:

  • Males or females, 18 years or older.
  • Patients with proven or probable IMI caused by Aspergillus spp. Patients who present with IMI due to other filamentous fungi (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi such as Mucor spp. or Rhizopus spp.) may also be enrolled.
  • Have limited or no treatment options due to documented or anticipated resistance, contraindication, intolerance, or lack of clinical response to SOC antifungal therapy, as advocated by the relevant regional/country treatment guidelines.
  • Patients where the Investigator considers that there is a potential advantage of using APX001 over current SOC (eg, broad spectrum of activity, emergence of IMI during antifungal prophylaxis, activity against resistant mold pathogens, IV and PO formulations, favorable DDI profile, favorable hepatic and renal safety profile, wide tissue distribution including brain), and/or where the SOC antifungal therapy carries significant risk of toxicity or treatment failure (eg, DDI risk, safety/toxicity risk, site of infection not accessible by SOC).

Exclusion Criteria:

  • Refractory hematologic malignancy.
  • Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
  • Treatment with systemic (PO, IV, or inhaled) mold active antifungal therapy for 120 hours immediately before initial dosing. Note: patients with invasive fungal infection caused by a mold with documented resistance to or lack of coverage by the prior SOC in question, may have received >120 hours prior treatment and remain eligible for the study.
  • Evidence of significant hepatic dysfunction.
Contacts and Locations
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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): NCT04240886


Contacts
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Contact: Susan Hazel +1.858.436.7204 shazel@amplyx.com

Locations
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United States, California
Clinical Trial Site Recruiting
Duarte, California, United States, 91010
Clinical Trial Site Recruiting
Sacramento, California, United States, 95616
Clinical Trial Site Recruiting
San Diego, California, United States, 92093
United States, Massachusetts
Clinical Trial Site Recruiting
Boston, Massachusetts, United States, 02115
United States, North Carolina
Clinical Trial Site Recruiting
Durham, North Carolina, United States, 27710
Belgium
Clinical Trial Site Active, not recruiting
Brussels, Belgium, 1000
Clinical Trial Site Recruiting
Brussels, Belgium, 1070
Clinical Trial Site Recruiting
Leuven, Belgium, 3000
Clinical Trial Site Recruiting
Yvoir, Belgium, 5530
Germany
Clinical Trial Site Recruiting
Koeln, Germany
Clinical Trial Site Recruiting
Mainz, Germany
Israel
Clinical Trial Site Recruiting
Haifa, Israel
Clinical Trial Site Recruiting
Tel Aviv, Israel
Clinical Trial Site Recruiting
Tel HaShomer, Israel
Sponsors and Collaborators
Amplyx Pharmaceuticals
More Information
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Responsible Party: Amplyx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04240886    
Other Study ID Numbers: APX001-202
2019-001386-33 ( EudraCT Number )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amplyx Pharmaceuticals:
fosmanogepix
APX001
APX001A
manogepix
aspergillus
aspergillosis
covid
covid19
mold
mould
pulmonary aspergillosis
pulmonary aspergillus
 galactomannan
Karius
SARS-CoV-2
fusarium
mucorales
mucor
rhizopus
scedosporium
fungal disease
invasive fungal disease
EORTC
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Mycoses
Invasive Fungal Infections
 Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses