Trial · NCT00404092
Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis
NCT00404092, Phase 2, Completed, University of Cologne; results first posted 2013-01-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis. Trials, record NCT00404092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00404092
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis
- NCT number
- NCT00404092
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- University of Cologne
- Conditions
- Invasive Aspergillosis
- Interventions
- caspofungin
- First posted
- 2006-11-27
- Last updated
- 2013-07-31
- Other registries' IDs
- eudract:2006-001936-30
- Results first posted
- 2013-01-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis | End of caspofungin treatment, treatment duration varied between 3 and 29 days (mean: 20.5; median: 24.5) | Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria. |
| Secondary | Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | End of caspofungin treatment; 4 weeks follow-up; 12 weeks follow-up | Numbers of patients in each dose cohort according to invasive aspergillosis (IA) outcome at end of protocol treatment (EOT), 4 weeks follow-up (4w FU) and 12 weeks follow-up (12w FU), respectively. 12w FU was only required for patients with a CR or PR at the 4w FU. Definitions: CR: resolution of all attributable symptoms, signs, and radiographic or bronchoscopic abnormalities. PR: clinically meaningful improvement in attributable symptoms, signs, and radiographic (min. 50% decrease) or bronchoscopic abnormalities. Stable disease (SD): no improvement in attributable symptoms, signs, and radiographic or bronchoscopic abnormalities. Failure: deterioration in attributable clinical or radiographic abnormalities necessitating alternative antifungal therapy or resulting in death. Relapse: reemergence of IA after EOT following CR, PR or SD or early withdrawal. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | End of caspofungin treatment; 4 weeks follow-up; 12 weeks follow-up | All 46 recruited patients were included in the analysis. 2 (EOT), 16 (4w FU) and 23 (12w FU) outcomes out of 46 were not recorded. | participants | NUMBER |
| PRIMARY | Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis | End of caspofungin treatment, treatment duration varied between 3 and 29 days (mean: 20.5; median: 24.5) | events | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | 1st Cohort | Favorable Response (CR&PR) | 4 | participants | |
| Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | 2nd Cohort | Favorable Response (CR&PR) | 3 | participants | |
| Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | 3rd Cohort | Favorable Response (CR&PR) | 6 | participants | |
| Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | 4th Cohort | Favorable Response (CR&PR) | 12 | participants | |
| Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | 1st Cohort | Complete Response (CR) | 0 | participants | |
| Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | 2nd Cohort | Complete Response (CR) | 0 | participants | |
| Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | 3rd Cohort | Complete Response (CR) | 1 | participants | |
| Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | 4th Cohort | Complete Response (CR) | 0 | participants | |
| Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | 1st Cohort | Partial Response (PR) | 4 | participants | |
| Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. | 2nd Cohort | Partial Response (PR) | 3 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1st Cohort | 9 | |
| Overall Study | STARTED | 2nd Cohort | 8 | |
| Overall Study | STARTED | 3rd Cohort | 9 | |
| Overall Study | STARTED | 4th Cohort | 20 | |
| Overall Study | COMPLETED | 1st Cohort | 8 | |
| Overall Study | COMPLETED | 2nd Cohort | 8 | |
| Overall Study | COMPLETED | 3rd Cohort | 8 | |
| Overall Study | COMPLETED | 4th Cohort | 20 | |
| Overall Study | NOT COMPLETED | 1st Cohort | 1 | |
| Overall Study | NOT COMPLETED | 2nd Cohort | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events936
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | intermittant ear pressure | Ear and labyrinth disorders | 1st Cohort | 1 | 9 | |
| other | intermittant ear pressure | Ear and labyrinth disorders | 2nd Cohort | 0 | 8 | |
| other | intermittant ear pressure | Ear and labyrinth disorders | 3rd Cohort | 0 | 9 | |
| other | intermittant ear pressure | Ear and labyrinth disorders | 4th Cohort | 0 | 20 | |
| other | pressure on the ears | Ear and labyrinth disorders | 1st Cohort | 0 | 9 | |
| other | pressure on the ears | Ear and labyrinth disorders | 2nd Cohort | 0 | 8 | |
| other | pressure on the ears | Ear and labyrinth disorders | 3rd Cohort | 1 | 9 | |
| other | pressure on the ears | Ear and labyrinth disorders | 4th Cohort | 0 | 20 | |
| other | anemia | Blood and lymphatic system disorders | 1st Cohort | 0 | 9 | |
| other | anemia | Blood and lymphatic system disorders | 2nd Cohort | 0 | 8 |
1 to 10 of 936Source ClinicalTrials.gov
See all 936 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1st Cohort | ||
| Total, all-cause mortality | 2nd Cohort | ||
| Total, all-cause mortality | 3rd Cohort | ||
| Total, all-cause mortality | 4th Cohort | ||
| Total, other adverse events | 1st Cohort | 9 | 9 |
| Total, other adverse events | 2nd Cohort | 8 | 8 |
| Total, other adverse events | 3rd Cohort | 9 | 9 |
| Total, other adverse events | 4th Cohort | 20 | 20 |
| Total, serious adverse events | 1st Cohort | 1 | 9 |
| Total, serious adverse events | 2nd Cohort | 5 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00404092
GET https://conductscience.org/api/trials/v1/NCT00404092/results?page=2