Trial · NCT02372006
Trial of Afatinib in Pediatric Tumours
NCT02372006, Phase 1, Phase 2, Completed, Boehringer Ingelheim; results first posted 2021-03-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Afatinib in Pediatric Tumours. Trials, record NCT02372006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02372006
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Afatinib in Pediatric Tumours
- NCT number
- NCT02372006
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Neuroectodermal Tumors, Rhabdomyosarcoma
- Interventions
- afatinib
- First posted
- 2015-02-26
- Last updated
- 2021-03-04
- Other registries' IDs
- eudract:2014-002123-10
- Results first posted
- 2021-03-04
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort | Assessed every 8 weeks until progression of disease, up to 336 days. | Number of participants with objective response for maximum tolerated dose expansion (MTD) cohort was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression. |
| Primary | Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Dose Finding Part | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8. | Area under the curve over dosing interval τ at steady state (AUCτ,ss) for Dose finding part was reported. |
| Primary | Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Dose Finding Part | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8. | Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for Dose finding part was reported. |
| Primary | Number of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part | During the first course (28 days) of treatment. | Number of participants with Dose Limiting Toxicity adverse events for Dose finding part was reported. |
| Secondary | Number of Participants With Objective Response - Dose Finding Part | Assessed every 8 weeks until progression of disease, up to 336 days. | Number of participants with objective response for Dose finding part was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression. |
| Secondary | Progression Free Survival - Maximum Tolerated Dose (MTD) Expansion Cohort | From the first treatment until date of first progression or death, up to 336 days. | Progression free survival for the MTD expansion cohorts was reported. Progression free survival (PFS) was defined as the duration from the date of first treatment until the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of last adequate tumour assessment. |
| Secondary | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) - Dose Finding Part | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration on Day 1. | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours (AUC0-24) for Dose finding part was reported. |
| Secondary | Maximum Measured Concentration (Cmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration on Day 1. | Maximum measured concentration (Cmax) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported. |
| Secondary | Time From (Last) Dosing to the Maximum Measured Concentration (Tmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration on Day 1. | Time from (last) dosing to the maximum measured concentration (tmax) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported. |
| Secondary | Time From (Last) Dosing to the Maximum Measured Concentration at Steady State (Tmax,ss) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8. | Time from (last) dosing to the maximum measured concentration at steady state (tmax,ss) for Dose finding part/maximum tolerated dose (MTD) expansion cohort was reported. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort | Assessed every 8 weeks until progression of disease, up to 336 days. | Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Dose Finding Part | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8. | Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis. | hours times nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Dose Finding Part | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8. | Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis. | nanogram per mililiter | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part | During the first course (28 days) of treatment. | Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Objective Response - Dose Finding Part | Assessed every 8 weeks until progression of disease, up to 336 days. | Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival - Maximum Tolerated Dose (MTD) Expansion Cohort | From the first treatment until date of first progression or death, up to 336 days. | Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication. | Months | MEDIAN |
| SECONDARY | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) - Dose Finding Part | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration on Day 1. | Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis. | hours times nanogram per mililiter | GEOMETRIC_MEAN |
| SECONDARY | Maximum Measured Concentration (Cmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration on Day 1. | Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis. | nanogram per mililiter | GEOMETRIC_MEAN |
| SECONDARY | Time From (Last) Dosing to the Maximum Measured Concentration (Tmax) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration on Day 1. | Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis. | Hours | MEDIAN |
| SECONDARY | Time From (Last) Dosing to the Maximum Measured Concentration at Steady State (Tmax,ss) - Dose Finding Part/Maximum Tolerated Dose (MTD) Expansion Cohort | Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8. | Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis. | Hours | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 3 | Participants | ||
| Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Dose Finding Part | Dose Finding - Level 0 | 681 | Geometric Coefficient of Variation 43.8 | hours times nanogram per milliliter | |
| Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Dose Finding Part | Dose Finding - Level 1 | 1380 | Geometric Coefficient of Variation 29.0 | hours times nanogram per milliliter | |
| Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Dose Finding Part | Dose Finding - Level 0 | 53.0 | Geometric Coefficient of Variation 48.8 | nanogram per mililiter | |
| Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Dose Finding Part | Dose Finding - Level 1 | 115 | Geometric Coefficient of Variation 39.3 | nanogram per mililiter | |
| Number of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part | Dose Finding - Level 0 | 1 | Participants | ||
| Number of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part | Dose Finding - Level 1 | 2 | Participants | ||
| Number of Participants With Objective Response - Dose Finding Part | Dose Finding - Level 0 | 0 | Participants | ||
| Number of Participants With Objective Response - Dose Finding Part | Dose Finding - Level 1 | 0 | Participants | ||
| Progression Free Survival - Maximum Tolerated Dose (MTD) Expansion Cohort | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 8.0 | 95% Confidence Interval 6.4 to 8.29 | Months |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Finding - Level 0 | 8 | |
| Overall Study | STARTED | Dose Finding - Level 1 | 9 | |
| Overall Study | STARTED | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 39 | |
| Overall Study | COMPLETED | Dose Finding - Level 0 | 0 | |
| Overall Study | COMPLETED | Dose Finding - Level 1 | 0 | |
| Overall Study | COMPLETED | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 0 | |
| Overall Study | NOT COMPLETED | Dose Finding - Level 0 | 8 | |
| Overall Study | NOT COMPLETED | Dose Finding - Level 1 | 9 | |
| Overall Study | NOT COMPLETED | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 39 |
Source ClinicalTrials.gov
Adverse events492
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 | Anaemia | Blood and lymphatic system disorders | Dose Finding - Level 0 | 3 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Finding - Level 1 | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 7 | 39 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dose Finding - Level 0 | 1 | 8 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dose Finding - Level 1 | 0 | 9 | |
| other | Leukopenia | Blood and lymphatic system disorders | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 0 | 39 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Dose Finding - Level 0 | 0 | 8 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Dose Finding - Level 1 | 1 | 9 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 2 | 39 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dose Finding - Level 0 | 1 | 8 |
1 to 10 of 492Source ClinicalTrials.gov
See all 492 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Finding - Level 0 | 8 | 8 |
| Total, all-cause mortality | Dose Finding - Level 1 | 9 | 9 |
| Total, all-cause mortality | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 29 | 39 |
| Total, other adverse events | Dose Finding - Level 0 | 8 | 8 |
| Total, other adverse events | Dose Finding - Level 1 | 9 | 9 |
| Total, other adverse events | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 38 | 39 |
| Total, serious adverse events | Dose Finding - Level 0 | 7 | 8 |
| Total, serious adverse events | Dose Finding - Level 1 | 6 | 9 |
| Total, serious adverse events | Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0 | 20 | 39 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose Finding - Level 0 vs Dose Finding - Level 1: Number of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part | Trial comparisons |
| Dose Finding - Level 0 vs Dose Finding - Level 1: Number of Participants With Objective Response - Dose Finding Part | 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/NCT02372006
GET https://conductscience.org/api/trials/v1/NCT02372006/results?page=2