A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy

NCT02895529 | Terminated Phase 4 DMC

• 2 other identifiers: CR108202R051211FUN4057
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to investigate the hypothesis that the efficacy of intravenous (IV) itraconazole followed by oral itraconazole is non-inferior to that of intravenous caspofungin as empiric therapy for suspected fungal infection participants with fever and neutropenia.

Conditions

Hematologic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints

  Response rate in each of the 2 treatment groups will be measured by the percentage of participants that achieve all of the following 5 composite endpoints: 1) survival for 7 days after completion of treatment, 2) absence of breakthrough invasive fungal infection during the study drug administration and within the first 7 days after completion of treatment, 3) successful treatment of baseline fungal infection, 4) defervescence and 5) no premature withdrawal from the study due to drug-related toxicity or lack of efficacy.

  Up to 36 days

Secondary Outcomes (6)

• Percentage of Participants With Survival for 7 Days After Completion of Treatment

  Up to 36 days

• Percentage of Participants With Absence of Breakthrough Invasive Fungal Infection

  Day 3 up to Day 28 (End of treatment [EoT]) and within 7 days after EoT (Day 29 up to Day 35)

• Percentage of Participants With Successful Treatment of Baseline Fungal Infection

  Screening up to Day 3

• Percentage of Participants With Defervescence During the Period of Neutropenia

  Up to 36 days

• Percentage of Participants With No Premature Withdrawal From the Study due to Drug-related Toxicity or Lack of Efficacy

  Up to 36 days

Study Arms (2)

Itraconazole

EXPERIMENTAL

Drug: Itraconazole

Caspofungin

ACTIVE COMPARATOR

Drug: Caspofungin

Interventions

Itraconazole DRUG

Participants will receive 200 milligram (mg) of itraconazole intravenously (IV) twice daily on Day 1 and Day 2, followed by 200 mg once daily through Day 14. From Day 15 to Day 28, participants will receive 200 mg (20 milliliters \[mL\]) of itraconazole oral solution orally twice daily. Participants, who are not suitable for oral administration of itraconazole based on the investigator's judgment, will receive 200 mg of itaconazole IV once daily from Day 15 to Day 28.

Itraconazole

Caspofungin DRUG

Participants will receive 70 mg of caspofungin IV once daily on Day 1 followed by 50 mg IV infusion once daily thereafter through Day 28.

Caspofungin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be hospitalized with hematologic malignancy treated by myelosuppressive therapy and/or Hematopoietic stem cell transplantation
• Participant must have a diagnosis of neutropenia with neutrophil count \< 500/microliters (mcL) (0.5 × 10\^9/ liters \[L\]) for at least 96 hours at screening
• Participant must have a diagnosis of fever and meet the following criteria: 1) Oral/rectal temperature greater than or equal to (\>=) 38 degree celsius or axillary temperature (\>=) 37.5 degree celsius and is not considered related to blood products transfusion or drug fever, 2) Not responding to broad-spectrum gram-positive and gram-negative antibiotics for 4-7 days with or without signs and symptoms that potentially attributable to deep fungal infection and 3) Defervescence within 3 days after the first broad-spectrum antibiotics but recurrence afterwards.
• A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[b hCG\]) and pregnancy test at screening
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study period and until the menstrual period following the end of study treatment

You may not qualify if:

• Is concomitantly using other systematic antifungal drugs as empirical treatment
• Has evidence of inadequately managed bacterial infection
• Is currently receiving any Cytochrome P450 3A4 (CYP3A4)-metabolized/P-glycoprotein-transported drugs (including but not limited to cisapride, pimozide, quinidine, dofetilide, levacetylmethadol, terfenadine, astemizole, mizolastine, bepridil, sertindole, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG-CoA reductase) inhibitor \[for example, simvastatin, lovastatin\], oral midazolam, triazolam, ergot alkaloids \[eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine\] and nisoldipine) that should be prohibited in this study
• Has known allergy, intolerance or hypersensitivity to azole and echinocandin antifungals or its excipients
• Has a contraindication to the use of sodium chloride injection

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (12)

Unknown Facility

Beijign, China

Location

Unknown Facility

Beijing, China

Location

Unknown Facility

Changchun, China

Location

Unknown Facility

Changzhou, China

Location

Unknown Facility

Fuzhou, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Guiyang, China

Location

Unknown Facility

Hefei, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Suzhou, China

Location

Unknown Facility

Tianjin, China

Location

Unknown Facility

Zhengzhou, China

Location

Related Links

• A Multicenter, Randomized Trial Comparing The Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Subjects With Hematological Malignancy

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Itraconazole; Caspofungin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 9, 2016
• Study Start: November 30, 2016
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: May 6, 2019

Record last verified: 2019-04

Locations

CN (12)