SUBA-Itraconazole Therapy for Coccidioidomycosis Refractory or Intolerant to Fluconazole

Withdrawn before enrolling · Phase 2

Conditions studied: Coccidioidomycosis, Valley Fever

In brief

The purpose of this study is to determine how safe, effective, and well tolerated a new investigational antifungal drug, SUBA-itraconazole, is for patients who have been previously treated with fluconazole and have had either an insufficient response to treatment with fluconazole or a negative reaction to fluconazole preventing their further treatment with it.

Key facts

Study ID

NCT04809649

Run by

George R Thompson

People needed

0

Starts

2021-05-15

Expected to finish

2022-09-01

Last updated by the study team

2021-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects ≥ 18 years who have given written informed consent to participate
• Subjects with a proven or probable coccidioidomycosis according to current European Organisation for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria, including subjects who:
• Are immunosuppressed, including as a result of HIV/AIDS
• Have had a heart, lung or bone marrow transplant
• Have had chemotherapy for cancer
• Are otherwise not immunocompromised
• Note: central nervous system (CNS) infection is an exclusionary criteria
• Refractory for ≥ 40 days, or intolerant to fluconazole treatment for coccidioidomycosis in the opinion of the investigator
• Refractory disease defined as failure to obtain an adequate therapeutic response after ≥40 days of therapy:
• Lack of improvement in signs, symptoms or imaging findings OR
• Continued isolate of Coccidioides or histopathologic findings of • Coccidioides despite antifungal therapy
• Rising Complement Fixation Titers
• Progression of disease (requires worsening of attributable signs, symptoms or imaging, or a new site of infection
• Intolerance defined as adverse events attributable to fluconazole therapy defined as organ toxicity of grade 3 or higher, nephrotoxicity (Creatinine twice the upper limit of normal), or idiosyncratic reactions therapy that in the opinion of the investigator may be relieved by a therapeutic change OR refusal of the patient to take further fluconazole
• Subjects of childbearing potential should be non-pregnant and not breastfeeding (and not planning to become pregnant)
• Postmenopausal for ≥1 year
• Post-hysterectomy or bilateral oophorectomy
• If of child-bearing potential have a negative pregnancy test at screening and using an acceptable effective method of birth control throughout course of study or remain abstinent for duration of study. Subjects with a partner of childbearing potential should agree to use appropriate contraception.

You may not qualify if…

• Significant liver dysfunction as evidenced by total bilirubin > 1.5 × the upper limit of normal (ULN) range unless considered due to Gilbert syndrome, in which case > 3 × the ULN, and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels > 1.5 x the ULN.
• Evidence of CNS infection.
• Unable to take PO medications.
• Documented intolerance, allergy or hypersensitivity to itraconazole.
• Inability to comply with study treatment, study visits, and study procedures.
• Known history or presence of congestive cardiac failure, fungal endocarditis, or other causes of ventricular dysfunction that may outweigh the benefit of itraconazole.
• Subjects with active tuberculosis.
• Concurrent use of drugs that effect SUBA™-itraconazole concentrations
• Subjects who washout from prohibited medications can be included
• Any known or suspected condition of the subject that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy.
• Treatment with any investigational agent in the 30 days prior to study entry.
• Subjects unlikely to survive 30 days based on the opinion of the investigator.
• Subjects with body weight < 40 kg.

Where it is running

• University of California, Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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