Trial Outcomes & Findings for A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED) (NCT NCT00717860)
NCT ID: NCT00717860
Last Updated: 2017-03-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
121 participants
Primary outcome timeframe
1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis
Results posted on
2017-03-23
Participant Flow
Participant milestones
| Measure |
Caspofungin
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.
|
Micafungin
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.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
|
Overall Study
COMPLETED
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
27
|
28
|
Reasons for withdrawal
| Measure |
Caspofungin
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.
|
Micafungin
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.
|
|---|---|---|
|
Overall Study
Clinical adverse experience
|
5
|
9
|
|
Overall Study
Laboratory adverse experience
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
7
|
13
|
|
Overall Study
Discontinued for other reason
|
6
|
1
|
|
Overall Study
Withdrew consent
|
7
|
3
|
Baseline Characteristics
A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Caspofungin
n=61 Participants
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.
|
Micafungin
n=60 Participants
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.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
69.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosisPopulation: All Participants as Treated (APaT) population.
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.
Outcome measures
| Measure |
Caspofungin
n=60 Participants
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.
|
Micafungin
n=60 Participants
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.
|
|---|---|---|
|
Number of Participants With a Significant Drug-related Adverse Experience
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosisPopulation: APaT population.
A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.
Outcome measures
| Measure |
Caspofungin
n=60 Participants
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.
|
Micafungin
n=60 Participants
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.
|
|---|---|---|
|
Number of Participants With a Specific Safety Finding
Drug-related adverse experience
|
23 Participants
|
25 Participants
|
|
Number of Participants With a Specific Safety Finding
Serious drug-related adverse experience
|
0 Participants
|
2 Participants
|
|
Number of Participants With a Specific Safety Finding
Discontinued by drug-related adverse experience
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosisPopulation: Per Protocol Set (PPS) population.
Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.
Outcome measures
| Measure |
Caspofungin
n=44 Participants
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.
|
Micafungin
n=41 Participants
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.
|
|---|---|---|
|
Number of Participants With Favorable Overall Response at the End of Study Therapy
Esophageal candidiasis (n=6, n=6)
|
6 Participants
|
5 Participants
|
|
Number of Participants With Favorable Overall Response at the End of Study Therapy
Invasive candidiasis (n=3, n=1)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Favorable Overall Response at the End of Study Therapy
Aspergillosis (n=30, n=33)
|
14 Participants
|
14 Participants
|
Adverse Events
Caspofungin
Serious events: 12 serious events
Other events: 44 other events
Deaths: 0 deaths
Micafungin
Serious events: 14 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caspofungin
n=60 participants at risk
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.
|
Micafungin
n=60 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.7%
1/60 • Number of events 1
|
0.00%
0/60
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
1.7%
1/60 • Number of events 1
|
0.00%
0/60
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.7%
1/60 • Number of events 1
|
0.00%
0/60
|
|
General disorders
Death
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
5.0%
3/60 • Number of events 3
|
3.3%
2/60 • Number of events 2
|
|
Infections and infestations
Infection
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
5.0%
3/60 • Number of events 3
|
0.00%
0/60
|
|
Infections and infestations
Sepsis
|
3.3%
2/60 • Number of events 2
|
0.00%
0/60
|
|
Infections and infestations
Septic shock
|
1.7%
1/60 • Number of events 1
|
0.00%
0/60
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.7%
1/60 • Number of events 1
|
0.00%
0/60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal mesothelioma malignant advanced
|
1.7%
1/60 • Number of events 1
|
0.00%
0/60
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
1/60 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.7%
1/60 • Number of events 1
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/60
|
1.7%
1/60 • Number of events 1
|
Other adverse events
| Measure |
Caspofungin
n=60 participants at risk
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.
|
Micafungin
n=60 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.0%
6/60 • Number of events 7
|
8.3%
5/60 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
3/60 • Number of events 3
|
11.7%
7/60 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
8.3%
5/60 • Number of events 5
|
6.7%
4/60 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
4/60 • Number of events 4
|
3.3%
2/60 • Number of events 3
|
|
General disorders
Injection site pain
|
6.7%
4/60 • Number of events 4
|
8.3%
5/60 • Number of events 7
|
|
General disorders
Malaise
|
6.7%
4/60 • Number of events 6
|
6.7%
4/60 • Number of events 4
|
|
General disorders
Oedema
|
6.7%
4/60 • Number of events 4
|
3.3%
2/60 • Number of events 2
|
|
General disorders
Pyrexia
|
8.3%
5/60 • Number of events 5
|
6.7%
4/60 • Number of events 6
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
4/60 • Number of events 4
|
8.3%
5/60 • Number of events 8
|
|
Infections and infestations
Pneumonia
|
8.3%
5/60 • Number of events 5
|
3.3%
2/60 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
6/60 • Number of events 8
|
11.7%
7/60 • Number of events 7
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
9/60 • Number of events 12
|
10.0%
6/60 • Number of events 7
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
3/60 • Number of events 3
|
15.0%
9/60 • Number of events 9
|
|
Investigations
Blood glucose increased
|
11.7%
7/60 • Number of events 7
|
5.0%
3/60 • Number of events 3
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.7%
4/60 • Number of events 5
|
6.7%
4/60 • Number of events 4
|
|
Investigations
Blood potassium decreased
|
10.0%
6/60 • Number of events 6
|
1.7%
1/60 • Number of events 1
|
|
Investigations
Blood potassium increased
|
5.0%
3/60 • Number of events 3
|
8.3%
5/60 • Number of events 5
|
|
Investigations
Blood pressure increased
|
5.0%
3/60 • Number of events 8
|
6.7%
4/60 • Number of events 4
|
|
Investigations
C-reactive protein increased
|
8.3%
5/60 • Number of events 5
|
6.7%
4/60 • Number of events 4
|
|
Investigations
Eosinophil count increased
|
5.0%
3/60 • Number of events 3
|
6.7%
4/60 • Number of events 4
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.0%
3/60 • Number of events 3
|
6.7%
4/60 • Number of events 4
|
|
Investigations
Whtie blood cell count increased
|
3.3%
2/60 • Number of events 2
|
11.7%
7/60 • Number of events 7
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
4/60 • Number of events 6
|
3.3%
2/60 • Number of events 2
|
|
Nervous system disorders
Headache
|
10.0%
6/60 • Number of events 7
|
8.3%
5/60 • Number of events 9
|
|
Psychiatric disorders
Insomnia
|
5.0%
3/60 • Number of events 3
|
6.7%
4/60 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
2/60 • Number of events 3
|
6.7%
4/60 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
5/60 • Number of events 6
|
3.3%
2/60 • Number of events 2
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER