Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00717860 | A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED) | PHASE3 | COMPLETED | 121 | — | — | Aug 1, 2008 | Jul 1, 2010 | Mar 23, 2017 | - | — |
| NCT00635648 | A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066) | PHASE3 | COMPLETED | 63 | — | — | Jan 1, 2008 | May 1, 2011 | Mar 24, 2017 | - | — |
| NCT00379964 | A 28 - 90 Days Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Injection as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia (0991-053)(COMPLETED) | PHASE3 | COMPLETED | 50 | — | — | Jun 1, 2005 | May 1, 2006 | Feb 23, 2017 | - | — |
| NCT00292071 | Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042) | PHASE2 | COMPLETED | 16 | — | — | May 1, 2004 | Jul 1, 2006 | Feb 23, 2017 | - | — |
A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.
A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention. A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.
| Arm | Type | Description |
|---|---|---|
| Caspofungin | EXPERIMENTAL | caspofungin acetate (MK0991) |
| Micafungin | ACTIVE_COMPARATOR | Micafungin sodium |
| Caspofungin 50 mg Intravenous (IV) | EXPERIMENTAL | - |
| 1 | OTHER | IV caspofungin acetate (50 mg/m²/day) |
| 2 | OTHER | IV caspofungin acetate (70 mg/m²/day) |
| Name | Type | Description |
|---|---|---|
| caspofungin acetate | DRUG | Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
| Comparator: Micafungin sodium | DRUG | Micafungin sodium 150 mg/day, once daily IV, for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. |
Inclusion Criteria: * Japanese Patients In Whom A Causative Fungus Is Detected Before Treatment With The Study Drug Or Patients With Strongly Suspected Deep-Seated Fungal Infection Due To Candida species (Spp.) Or Aspergillus Spp. Exclusion Criteria: * Patients With Mycoses Other Than Ones Due To...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| IQVIA Holdings Inc | IQV | 1 | PHASE3 | Olorofim, AmBisome |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Posaconazole /kg, Posaconazole PFS /kg |
| SCYNEXIS, Inc. | SCYX | 1 | — | Undisclosed |
| Innate Pharma SA Sponsored ADR | IPHA | 1 | — | Undisclosed |
| Gilead Sciences, Inc. | GILD | 1 | — | Undisclosed |