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Clinical Trials/EUCTR2016-000919-33-DE
EUCTR2016-000919-33-DE
Active, not recruiting
Phase 1

An open label phase IIa clinical study to evaluate the safety and pharmacokinetics of intravenous and oral F901318 (combined with caspofungin) for antifungal prophylaxis in patients undergoing chemotherapy for acute myeloid leukaemia (SAFEGUARD) - SAFEGUARD

F2G Limited0 sites10 target enrollmentJuly 11, 2016
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ConditionsInfasive fungal disease in patients with acute myeloid leukemia under chemotherapyMedDRA version: 19.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsCancidas®

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Infasive fungal disease in patients with acute myeloid leukemia under chemotherapy
Sponsor
F2G Limited
Enrollment
10
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 11, 2016
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
F2G Limited

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients diagnosed with AML and entering treatment of chemotherapy.
  • •2\.Patients are expected to be neutropenic (\< 500 ANC/µl) for \> 10 days.
  • •3\.Provision of written informed consent prior to any study specific procedures.
  • •4\.Ability and willingness to comply with the protocol.
  • •5\.Patients aged over 18 years.
  • •6\.Patient has or will receive within 2 days a multi\-lumen central venous catheter as standard of care.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 8

Exclusion Criteria

  • •1\.Documented lung infiltrate at screening.
  • •2\.Documented serum GMI \=0\.5 at screening
  • •3\.Current IFD or prior history of IFD or patients who received systemic antifungal therapy for proven or probable IFD in the last 12 months.
  • •4\.Patients who received any systemic antifungal therapy for more than 72 hours immediately prior to first administration of study medication. Echinocandins and topical polyenes or nystatin are acceptable. Posaconazole and other azoles have to be discontinued at least 3 days before start of F901318\.
  • •5\.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).
  • •6\.Documented prolongation of the QTc interval (\>450 ms).\*
  • •7\.Concomitant medication that prolongs QT interval (except for cytostatic drugs used during chemotherapy, such as mitoxantrone).
  • •8\.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.
  • •9\.History of convulsion.
  • •10\.Female patients only: Positive result of pregnancy test or breastfeeding.

Outcomes

Primary Outcomes

Not specified

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