Trial · NCT01592045
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
NCT01592045, Phase 1, Phase 2, Completed, United Therapeutics; results first posted 2015-09-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma. Trials, record NCT01592045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01592045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
- NCT number
- NCT01592045
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- United Therapeutics
- Conditions
- Neuroblastoma
- Interventions
- ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Aldesleukin (IL-2), Isotretinoin
- First posted
- 2012-05-04
- Last updated
- 2015-09-23
- Results first posted
- 2015-09-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration Curve (AUC) | PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment | Twenty-two PK samples will be obtained at the following timepoints: Courses 1 and 3: Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample Courses 2 and 4: Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin |
| Primary | Peak Plasma Concentration (Cmax) | PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment | Twenty-two PK samples will be obtained at the following timepoints: Courses 1 and 3: Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample Courses 2 and 4: Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration Curve (AUC) | PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment | mcg*hr/mL | MEAN | |
| PRIMARY | Peak Plasma Concentration (Cmax) | PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration Curve (AUC) | UTC ch14.18 | 518 | Standard Deviation 418 | mcg*hr/mL | |
| Area Under the Plasma Concentration Curve (AUC) | NCI ch14.18 | 470 | Standard Deviation 376 | mcg*hr/mL | |
| Peak Plasma Concentration (Cmax) | UTC ch14.18 | 6468 | Standard Deviation 719 | ng/mL | |
| Peak Plasma Concentration (Cmax) | NCI ch14.18 | 6689 | Standard Deviation 853 | ng/mL |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence 1 | 14 | |
| Overall Study | STARTED | Sequence 2 | 14 | |
| Overall Study | Completed Course 1 | Sequence 1 | 13 | |
| Overall Study | Completed Course 1 | Sequence 2 | 14 | |
| Overall Study | Completed Course 2 | Sequence 1 | 13 | |
| Overall Study | Completed Course 2 | Sequence 2 | 13 | |
| Overall Study | Completed Course 3 | Sequence 1 | 11 | |
| Overall Study | Completed Course 3 | Sequence 2 | 13 | |
| Overall Study | Completed Course 4 | Sequence 1 | 11 | |
| Overall Study | Completed Course 4 | Sequence 2 | 12 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events286
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 | Pyrexia | General disorders | UTC ch14.18 | 27 | 27 | 71 |
| other | Pyrexia | General disorders | NCI ch14.18 | 27 | 27 | 64 |
| other | Pain | General disorders | UTC ch14.18 | 16 | 27 | 28 |
| other | Pain | General disorders | NCI ch14.18 | 12 | 27 | 22 |
| other | Platelet Count Decreased | Investigations | UTC ch14.18 | 12 | 27 | 18 |
| other | Platelet Count Decreased | Investigations | NCI ch14.18 | 12 | 27 | 17 |
| other | Alanine Aminotransferase Increased | Investigations | UTC ch14.18 | 18 | 27 | 27 |
| other | Alanine Aminotransferase Increased | Investigations | NCI ch14.18 | 9 | 27 | 15 |
| other | Neutrophil Count Decreased | Investigations | UTC ch14.18 | 11 | 27 | 19 |
| other | Neutrophil Count Decreased | Investigations | NCI ch14.18 | 9 | 27 | 11 |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | UTC ch14.18 | ||
| Total, all-cause mortality | NCI ch14.18 | ||
| Total, other adverse events | UTC ch14.18 | 27 | 27 |
| Total, other adverse events | NCI ch14.18 | 27 | 27 |
| Total, serious adverse events | UTC ch14.18 | 17 | 27 |
| Total, serious adverse events | NCI ch14.18 | 12 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| UTC ch14.18 vs NCI ch14.18: serious adverse events |
Source Trial comparisons
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/NCT01592045
GET https://conductscience.org/api/trials/v1/NCT01592045/events?page=2