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| ID | Type | Description | Link |
|---|---|---|---|
| R051211FUN4057 | Other Identifier | Xian-Janssen Pharmaceutical Ltd., China |
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Study is a commitment for license renew, we target on Apr19 submission, considering timeline, a cut off should be scheduled in Apr18.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole | Experimental |
| |
| Caspofungin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Absence of breakthrough invasive fungal infection is defined as the clinically or/and microbiologically documented fungal infection with an onset on or after day 3 of the study treatment during the study drug administration and within the first 7 days after completion of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijign | China | |||||
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| Label | URL |
|---|---|
| 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 | View source |
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| 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. |
|
| 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 | Successful treatment of baseline fungal infection is defined as the clinically and microbiologically documented fungal infection with an onset within screening to 2 days after the study treatment. | Screening up to Day 3 |
| Percentage of Participants With Defervescence During the Period of Neutropenia | Defervescence is defined as oral/rectal temperature less than (<) 38 degree celsius or axillary temperature (<) 37.5 degree celsius for over 48 hours) 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 |
| Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints With Oral Administration of Itraconazole | Response rate will be measured by the percentage of participants (who received oral administration of itraconazole) 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 |
| Beijing |
| China |
| Changchun | China |
| Changzhou | China |
| Fuzhou | China |
| Guangzhou | China |
| Guiyang | China |
| Hefei | China |
| Shanghai | China |
| Suzhou | China |
| Tianjin | China |
| Zhengzhou | China |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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