Know Cancer

or
forgot password

A Phase III, Randomized, Double-Blind, Comparative Trial of FK463 Versus Fluconazole for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoetic Stem Cell Transplant


Phase 3
N/A
N/A
Not Enrolling
Both
Aspergillosis, Candidiasis, Fungemia, Mycoses

Thank you

Trial Information

A Phase III, Randomized, Double-Blind, Comparative Trial of FK463 Versus Fluconazole for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoetic Stem Cell Transplant


The objective of this study is to determine the efficacy and safety of FK463 versus
fluconazole in preventing fungal infections in patients undergoing an autologous (for
hematologic malignancies) or allogeneic hematopoietic stem cell transplant. This is a Phase
III, multicenter, randomized, double-blind study in patients six months of age and older.
Study drug, either FK463 at 50 mg/day (1.0 mg/kg/day in patients weighing less than 50 kg)
or fluconazole at 400 mg/day (8 mg/kg/day in patients weighing less than 50 kg), will be
administered intravenously once daily in a blinded manner. Study drug will continue until
neutrophil recovery (defined as a post nadir absolute neutrophil count (ANC) of greater than
or equal to 500/mm3). Patients who develop a proven, probable, or suspected (requires
empirical antifungal therapy) fungal infection will be discontinued from the prophylactic
regimen. The maximum time the patient may receive study drug is 42 days post transplant.

Inclusion Criteria


Informed consent of the patient or legally authorized representative must be obtained
prior to entry.

Verbal assent will be obtained from minors capable of understanding.

Patients may be of either gender. Females of childbearing potential must have a negative
pregnancy test obtained within 14 days prior to the first dose of study drug.

Patients greater than or equal to 6 months of age.

Patients at risk of systemic fungal infections due to their immunocompromised state due to
one of the following:

Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell
transplant;

Any patient undergoing an allogeneic hematopoietic stem cell transplant.

Patients must have sufficient venous access to permit administration of study drug and
monitoring of safety variables.

No patients who are pregnant or nursing. Females of childbearing potential must avoid
becoming pregnant by abstinence or barrier methods of birth control while receiving
antifungal agents.

No patients with moderate or severe liver disease, as defined by:

AST or ALT greater than 5 times upper limit of normal (ULN), OR;

Total bilirubin greater than 2.5 times ULN.

No patients with evidence of a deeply invasive or disseminated fungal infection at time of
enrollment.

No patients who have received systemic antifungal agents within 72 hours prior to the
first dose of study drug.

No patients receiving an autologous transplant for nonhematologic malignancies.

No patients known to be infected with HIV due to the lack of data on drug interaction
between highly active antiretroviral therapy (HAART) and FK463.

No patients previously randomized in this study.

No patients with a history of anaphylaxis attributed to azole compounds or the
echinocandin class or antifungals.

No patients with a concomitant medical condition, in the opinion of the investigator
and/or medical monitor, whose participation may create an unacceptable additional risk for
the patient.

No patients receiving another investigational drug other than for the treatment of cancer
or supportive care.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

000014

NCT ID:

NCT00001937

Start Date:

November 1999

Completion Date:

December 2000

Related Keywords:

  • Aspergillosis
  • Candidiasis
  • Fungemia
  • Mycoses
  • Aspergillosis
  • Candidiasis
  • Fungal Infections
  • Fungemia
  • Prophylactic Antifungal Therapy
  • Aspergillosis
  • Candidiasis
  • Mycoses
  • Fungemia

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892