AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 1/2SAFEGUARDFPNCT03036046

Safety and Pharmacokinetics of Oral F901318 (Fluconazole and Posaconazole) IN Aml Leukaemia

A Phase 1/2 study testing F901318 with fluconazole low dose, F901318 with fluconazole high dose and F901318 with posaconazole in people with Acute Myeloid Leukemia, run by F2G Ltd.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Non-randomized, multi-centre, open label, uncontrolled, multiple dose, phase IIa study. A total of 18 patients diagnosed with acute myeloid leukaemia (AML) scheduled for chemotherapy and expected to be neutropenic (<500 Absolute neutrophil count (ANC)/µl) for >10 days will be treated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
F901318 with fluconazole low dose, F901318 with fluconazole high dose and F901318 with posaconazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2017to Mar 2018
Phase
Phase 1/2
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

  • Participating patients need to fulfil all of the following criteria:
  • Patients diagnosed with AML and entering treatment of chemotherapy.
  • Patients are expected to be neutropenic (ANC <500/µl) for >10 days.
  • Provision of written informed consent prior to any study specific procedures.
  • Ability and willingness to comply with the protocol.
  • Patients aged over 18 years.
Show all 12Show fewer
  • Patients with body weight ≥60 kg
  • Group F only: patient receives according to local clinical standard either
  • no fungal prophylaxis or
  • only topical fungal prophylaxis (e.g. Ampho moronal®) or
  • fluconazole as routine fungal prophylaxis
  • Group P only: patient receives posaconazole as fungal prophylaxis according to local clinical standard

Who cannot join

  • Any of the following will exclude a patient from the study:
  • Documented lung infiltrate at screening.
  • Evidence for active fungal infection, such as documented serum GMI ≥0.5 at screening (within 5 days before study start)
  • Current IFD or prior history of IFD or patients who received systemic antifungal therapy for proven or probable IFD in the last 12 months.
  • Patients who received any systemic antifungal therapy for more than 72 hours immediately prior to first administration of study medication. Echinocandins, posaconazole (group P, see also inclusion criterion 8), and topical polyenes or nystatin are acceptable.
  • Concomitant exposure to phenobarbital and long acting barbiturates, triazolam, carbamazepine, phenytoin, pimozide, cisaprid, efavirenz, ritonavir, rifabutin, rifampicin, ergot alkaloids (ergotamine, dihydroergotamin), ibrutinib, idelalisib, vinca alkaloids, digoxin, dofetilide, quinidine, St. John´s wort, everolimus, sirolimus, astemizole, terfenadine, methadone, alfentanil, fentanyl and other structurally related opiates, warfarin (see also section 8.8 for details).
Show all 25Show fewer
  • Documented prolongation of the QTc interval (>450 ms).
  • Concomitant medication that prolongs QT interval (except for cytostatic drugs used during chemotherapy, such as mitoxantrone).
  • Any other concomitant medical condition that, in the opinion of the investigator, may be an unacceptable additional risk to the patient should he/she participate in the study.
  • History of convulsion.
  • Female patients only: Positive result of pregnancy test or breastfeeding.
  • Female patients of childbearing potential who do not practice sexual abstinence as their common way of life and confirm to stay sexually abstinent also during their participation in the study or who do not use or do not agree to use appropriate contraceptive methods (prior to and during the study, including 14 days after the last dose of study therapy) as defined in ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals (EMA/CPMP/ICH/286/1995). Hormonal contraception alone is not considered appropriate. See section 9.3.2 for additional information.
  • Known hypersensitivity to any component of the study medication.
  • A history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, cardiomyopathy, sinus bradycardia, symptomatic arrhythmias, family history of long QT Syndrome).
  • Patient has had acute hepatitis in the prior 6 months, chronic hepatitis, cirrhosis (any Child-Pugh class), acute hepatic failure, or acute decompensation of chronic hepatic failure
  • Presence of hepatic disease as indicated by aspartate aminotransferase (AST) or alanine transaminase (ALT) >3 × upper limit of normal (ULN) at Screening. Patients with AST and/or ALT >3 × ULN and <5 × ULN are eligible if these elevations are acute, not accompanied by a total bilirubin ≥2xULN and documented by the investigator as being directly related to an infectious process being treated. During the clinical study, the investigator is responsible for, without delay, determining whether the patient meets potential Hy's law criteria (according to FDA [16]).
  • Patient has a total bilirubin >3 × ULN, unless isolated hyperbilirubinemia is directly related to an acute infection or due to known Gilbert's disease.
  • Calculated creatinine clearance (CrCl) <50 mL/minute.
  • Medical history of oliguria (<20 mL/h) unresponsive to fluid challenge.
  • Suspected other or additional cause for neutropenia or immunosuppression (other than AML or myelodysplastic syndrome).
  • Any other medical condition, which may affect the clinical evaluability of the patient.
  • Patients previously enrolled in this study.
  • Patient has participated or intends to participate in any other clinical study that involves the administration of an investigational medication at the time of presentation, during the course of the study, or during the 30 days prior to study start. New combinations of labelled substances for chemotherapy are allowed.
  • Chronic external ocular disease
  • Contact lens use intended during study treatment.

About this study

Official title: An Open Label Phase IIa Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral F901318 (Combined With Fluconazole and Posaconazole) in AML

Non-randomized, multi-centre, open label, uncontrolled, multiple dose, phase IIa study.

A total of 18 patients diagnosed with acute myeloid leukaemia (AML) scheduled for chemotherapy and expected to be neutropenic (<500 Absolute neutrophil count (ANC)/µl) for >10 days will be treated. F901318 will be given in conjunction with fluconazole or posaconzaole in order to assess safe treatment regimens for both combinations.

Read the detailed description

'F901318 has potent in vitro efficacy against Aspergillus spp. including azole-resistant strains and consistent efficacy in in vivo mouse models of infection. F901318 is active by both oral and intravenous routes of administration in preclinical efficacy studies.

Non-clinical studies and phase I clinical trials show that F901318 has a good overall safety profile and limited potential for drug-drug interactions. F901318 exhibits a highly promising profile which can potentially address the critical treatment requirements for invasive Aspergillus infections in a changing clinical environment in which new classes of antifungals are needed.

This phase IIa study aims to confirm PK and safety information of F901318 from phase I and bridge them to a neutropenic AML patient population, which represents the main population for future efficacy trials. Coadministration of fluconazole or posaconazole will allow recognizing potential factors of suboptimal F901318 exposure without the risk of fatal disseminating infection.'

Being tested
F901318 with fluconazole low dose, F901318 with fluconazole high dose, F901318 with posaconazole
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • F901318 with fluconazole low doseDrug

    adverse events

  • F901318 with fluconazole high doseDrug

    adverse events

  • F901318 with posaconazoleDrug

    adverse events

Study groups in NCT03036046
Study groupRoleWhat they receive
F901318 with fluconazole low doseExperimentalsafety assessment
Receives: Drug: F901318 with fluconazole low dose
F901318 with fluconazole high doseExperimentalsafety assessment
Receives: Drug: F901318 with fluconazole high dose
F901318 with posaconazoleExperimentalsafety assessment
Receives: Drug: F901318 with posaconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (adverse events)

    Adverse events

    Measured: 63 days

Secondary outcomes (1)

  1. Pharmacokinetics (Area under concentration/time curve)

    Area under concentration/time curve

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2017 (estimated)
  2. Study startMar 2017 (estimated)
  3. Primary completionSep 2017 (estimated)
  4. Study completionMar 2018 (estimated)

Why it stopped: Study no longer required

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Patients in group low dose fluconazole will be enrolled ahead of group high dose fluconazole. Group posaconazole will be enrolled in parallel according to prevaling practice in the institutions involved in the study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03036046
Sponsor's protocol ID
F901318C21
Acronym
SAFEGUARDFP
Status last verified
Feb 2018
First submitted
20 Jan 2017
Last updated
15 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing F901318 with fluconazole low dose, F901318 with fluconazole high dose and F901318 with posaconazole in people with Acute Myeloid Leukemia, run by F2G Ltd.

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 12 inclusion and 25 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 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety (adverse events) (time frame: 63 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03036046.

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 15 Feb 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in