CoccidioidomycosisPhase 2SITRISNCT04809649
SUBA-Itraconazole Therapy for Coccidioidomycosis Refractory or Intolerant to Fluconazole
A Phase 2 study testing SUBA-itraconazole in people with Coccidioidomycosis and Valley Fever, run by George R Thompson at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coccidioidomycosis, Valley Fever
- What is being tested?
- SUBA-itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
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.
Read the detailed description
This is a prospective, multi-center, open-label study involving subjects with proven or probable coccidioidomycosis refractory to fluconazole therapy following >40 days of treatment or subjects with proven or probable coccidioidomycosis who are intolerant to fluconazole.
The availability "Super Bioavailability" (SUBA) itraconazole 65 mg capsules with twice-daily dosing options with improved pharmacokinetics and lack of food or acidity requirements offers a substantial opportunity to improve the treatment of subjects with coccidioidomycosis.
- Conditions
- Coccidioidomycosis, Valley Fever
- Being tested
- SUBA-itraconazole
- Medical subject headings
- Coccidioidomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUBA-itraconazoleDrug
Also called Tolsura
Participant will receive treatment with SUBA-itraconazole
| Study group | Role | What they receive |
|---|---|---|
| SUBA-itraconazole | Experimental | Drug: SUBA-itraconazole Dosage Form: 65 mg capsules Dosage: 260 mg/day Frequency: 130 mg twice daily (BID) Duration: Up to 180 days Receives: Drug: SUBA-itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. The Proportion of Participants Who Achieve Clinical Improvement, in All Participants Who Took at Least One Dose of Study Drug
Clinical Improvement is defined as at a) at least a 50% reduction in coccidioidomycosis Mycoses Study Group (MSG Score) from baseline value, or b) the unequivocal documentation of clinical improvement as recorded on the progress note of the medical provider, or c) a 25%-49% decrease in the MSG score from baseline value and a physician's impression of improvement as recorded on the progress note. The MSG score is a composite scoring system that has been used in numerous past studies of coccidioidomycosis. This system comprises the sum of points assigned based on the findings of: (1) clinical assessments, (2) radiographic imaging, and (3) serologic assays, with a lower score indicating better health.
Measured: 180 days
Secondary outcomes (7)
Number of Participants with Treatment-Emergent Adverse Events
Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state. Severity grading will be based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. This is a descriptive scoring system which can be used for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Measured: 180 days
Number of Participants with Abnormal Laboratory Evaluations of Safety
Abnormal is defined as at least a 1 grade shift from baseline. Severity grading will be based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. This is a descriptive scoring system which can be used for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Measured: 180 days
Number of Participant Discontinuations of Therapy Due to Treatment-Emergent Adverse Events and/or Laboratory Evaluations of Safety
Number of Participant Discontinuations of Therapy Due to Treatment-Emergent Adverse Events and/or Laboratory Evaluations of Safety
Measured: 180 days
Number of Participants with Any Interruptions of Therapy due to Treatment-Emergent Adverse Events and/or Abnormal Laboratory Evaluations of Safety
Number of Participants with Any Interruptions of Therapy due to Treatment-Emergent Adverse Events and/or Abnormal Laboratory Evaluations of Safety
Measured: 180 days
Number of Participants with Interruptions of Therapy 7 Days or More in Duration due to Treatment-Emergent Adverse Events and/or Abnormal Laboratory Evaluations of Safety
Number of Participants with Interruptions of Therapy 7 Days or More in Duration due to Treatment-Emergent Adverse Events and/or Abnormal Laboratory Evaluations of Safety
Measured: 180 days
Mean, Median, and Quartile Score Values for Mental Component Summary and Physical Component Summary Scores of the SF-12v2 Survey
The Short Form 12 Question Health Survey, version 2 (SF-12v2) is a 12-question multipurpose survey instrument derived from the larger, Short Form 36 Question Survey. The SF-12v2 is to help determine the participant's overall state of wellbeing and health-related quality of life by means of assessing both physical and mental status at the time of the survey. The 8 domains of the survey are: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role- emotional (RE), and mental health (MH). Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions. MCS and PCS values can range from 0 to 100, where a higher score indicates better health.
Measured: 42 days
Mean, Median, and Quartile Score Values for Mental Component Summary and Physical Component Summary Scores of the SF-12v2 Survey
The Short Form 12 Question Health Survey, version 2 (SF-12v2) is a 12-question multipurpose survey instrument derived from the larger, Short Form 36 Question Survey. The SF-12v2 is to help determine the participant's overall state of wellbeing and health-related quality of life by means of assessing both physical and mental status at the time of the survey. The 8 domains of the survey are: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role- emotional (RE), and mental health (MH). Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions. MCS and PCS values can range from 0 to 100, where a higher score indicates better health.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start15 May 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Sponsor is not proceeding with study due to budget cuts as a result of COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccidioidomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George R Thompson
- Sponsor type
- University, hospital or other
- Collaborators
- Mayne Pharma International Pty Ltd
- Responsible party
- Sponsor-investigator, George R Thompson, University of California, Davis
- Investigators
- George R Thompson, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809649
- Sponsor's protocol ID
- 1666482
- Acronym
- SITRIS
- Status last verified
- Jul 2021
- First submitted
- 1 Mar 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUBA-Itraconazole Therapy for Coccidioidomycosis Refractory or Intolerant to Fluconazole
- ClinicalTrials.gov ID
- NCT04809649
- Acronym / sponsor ID
- SITRIS / 1666482
- Conditions
- Coccidioidomycosis, Valley Fever
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor is not proceeding with study due to budget cuts as a result of COVID-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George R ThompsonUniversity, hospital or other
- Collaborators
- Mayne Pharma International Pty Ltd
- Study start
- 15 May 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multi-center, open-label study involving subjects with proven or probable coccidioidomycosis refractory to fluconazole therapy following >40 days of treatment or subjects with proven or probable coccidioidomycosis who are intolerant to fluconazole.
The availability "Super Bioavailability" (SUBA) itraconazole 65 mg capsules with twice-daily dosing options with improved pharmacokinetics and lack of food or acidity requirements offers a substantial opportunity to improve the treatment of subjects with coccidioidomycosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUBA-itraconazole | Experimental | Drug: SUBA-itraconazoleDrug: SUBA-itraconazole Dosage Form: 65 mg capsules Dosage: 260 mg/day Frequency: 130 mg twice daily (BID) Duration: Up to 180 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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
- Subjects of childbearing potential should be non-pregnant and not breastfeeding (and not planning to become pregnant)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUBA-itraconazoleAlso: TolsuraParticipant will receive treatment with SUBA-itraconazole | Drug | SUBA-itraconazole |
Primary outcome
1. The Proportion of Participants Who Achieve Clinical Improvement, in All Participants Who Took at Least One Dose of Study Drug
Time frame: 180 days
Clinical Improvement is defined as at a) at least a 50% reduction in coccidioidomycosis Mycoses Study Group (MSG Score) from baseline value, or b) the unequivocal documentation of clinical improvement as recorded on the progress note of the medical provider, or c) a 25%-49% decrease in the MSG score from baseline value and a physician's impression of improvement as recorded on the progress note. The MSG score is a composite scoring system that has been used in numerous past studies of coccidioidomycosis. This system comprises the sum of points assigned based on the findings of: (1) clinical assessments, (2) radiographic imaging, and (3) serologic assays, with a lower score indicating better health.
7 secondary outcomes
Number of Participants with Treatment-Emergent Adverse Events
Time frame: 180 days
Number of Participants with Abnormal Laboratory Evaluations of Safety
Time frame: 180 days
Number of Participant Discontinuations of Therapy Due to Treatment-Emergent Adverse Events and/or Laboratory Evaluations of Safety
Time frame: 180 days
Number of Participants with Any Interruptions of Therapy due to Treatment-Emergent Adverse Events and/or Abnormal Laboratory Evaluations of Safety
Time frame: 180 days
Number of Participants with Interruptions of Therapy 7 Days or More in Duration due to Treatment-Emergent Adverse Events and/or Abnormal Laboratory Evaluations of Safety
Time frame: 180 days
Mean, Median, and Quartile Score Values for Mental Component Summary and Physical Component Summary Scores of the SF-12v2 Survey
Time frame: 42 days
Mean, Median, and Quartile Score Values for Mental Component Summary and Physical Component Summary Scores of the SF-12v2 Survey
Time frame: 180 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George R Thompson, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SUBA-itraconazole in people with Coccidioidomycosis and Valley Fever, run by George R Thompson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. The Proportion of Participants Who Achieve Clinical Improvement, in All Participants Who Took at Least One Dose of Study Drug (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.