Trial · NCT02573324
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
NCT02573324, Phase 3, Completed, AbbVie; results first posted 2023-05-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification. Trials, record NCT02573324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02573324
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
- NCT number
- NCT02573324
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 691 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Glioblastoma, Gliosarcoma
- Interventions
- Temozolomide, Depatuxizumab mafodotin, Radiation, Placebo for ABT-414
- First posted
- 2015-10-09
- Last updated
- 2023-05-11
- Other registries' IDs
- eudract:2015-001166-26
- Results first posted
- 2023-05-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. |
| Secondary | OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. Unmethylated MGMT promoter is associated with a worse prognosis in GBM |
| Secondary | OS for the MGMT Methylated Group | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. |
| Secondary | OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. |
| Secondary | Progression-Free Survival (PFS) | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria (see Wen et al. J Clin Oncol. 2010 Apr 10;28(11):1963-72) or to the date of death, if disease progression does not occur. |
| Secondary | PFS for EGFRvIII-Mutated Tumor Subgroup | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur. |
| Secondary | Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom severity score is defined as average over 13 core symptom items and 9 brain tumor symptom items, with a total score of 0 to 10, with higher score indicating worse symptoms/interference. Changes in symptom severity score were classified into 3 categories: improved (≤ -1), stable (\> -1 and \< 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom severity score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death. |
| Secondary | Deterioration Free Survival in MDASI-BT Symptom Interference Score | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom interference score is defined as an average of 6 interference items, with a total score of 0 to 10, where higher scores indicate worse interference. Changes in symptom interference score were classified into 3 categories: improved (≤ -1), stable (\> -1 and \< 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom interference score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death. |
| Secondary | Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. When scoring the HVLT-R, the 3 learning trials are combined to calculate a total recall score (range -12 to 60). Deterioration is defined as satisfying the deterioration criteria (i.e., decrease in HVLT-R total recall score by 5 units) without further improvement within 8 weeks or occurrence of death. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) | months | MEDIAN |
| SECONDARY | OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) Participants with unmethylated MGMT promoter status. | months | MEDIAN |
| SECONDARY | OS for the MGMT Methylated Group | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) Participants with methylated MGMT promoter status. | months | MEDIAN |
| SECONDARY | OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) Participants with EGFR-VIII mutation status=mutated. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) | months | MEDIAN |
| SECONDARY | PFS for EGFRvIII-Mutated Tumor Subgroup | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) Participants with EGFR-VIII mutation status=mutated. | months | MEDIAN |
| SECONDARY | Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) | months | MEDIAN |
| SECONDARY | Deterioration Free Survival in MDASI-BT Symptom Interference Score | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) | months | MEDIAN |
| SECONDARY | Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score | Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6). | Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:~* Enrollment date was on or prior to 31-Mar-2018~* Enrolled in the main study (not in the open-label hepatic sub-study) | months | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Placebo, Radiation and TMZ | 18.7 | 95% Confidence Interval 17.0 to 20.3 | months | |
| Overall Survival (OS) | Depatuxizumab Mafodotin, Radiation and TMZ | 18.9 | 95% Confidence Interval 17.4 to 20.8 | months | |
| OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group | Placebo, Radiation and TMZ | 16.2 | 95% Confidence Interval 14.7 to 17.7 | months | |
| OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group | Depatuxizumab Mafodotin, Radiation and TMZ | 16.1 | 95% Confidence Interval 14.6 to 18.5 | months | |
| OS for the MGMT Methylated Group | Placebo, Radiation and TMZ | NA | 95% Confidence Interval 21.2 to NA | months | |
| OS for the MGMT Methylated Group | Depatuxizumab Mafodotin, Radiation and TMZ | 25.4 | 95% Confidence Interval 21.6 to 27.3 | months | |
| OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup | Placebo, Radiation and TMZ | 18.2 | 95% Confidence Interval 15.7 to 19.5 | months | |
| OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup | Depatuxizumab Mafodotin, Radiation and TMZ | 19.8 | 95% Confidence Interval 17.8 to 23.1 | months | |
| Progression-Free Survival (PFS) | Placebo, Radiation and TMZ | 6.3 | 95% Confidence Interval 5.9 to 7.9 | months | |
| Progression-Free Survival (PFS) | Depatuxizumab Mafodotin, Radiation and TMZ | 8.0 | 95% Confidence Interval 6.2 to 9.6 | months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo, Radiation and Temozolomide (TMZ) | 341 | |
| Overall Study | STARTED | Depatuxizumab Mafodotin, Radiation and TMZ | 344 | |
| Overall Study | STARTED | Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ | 6 | |
| Overall Study | Received Randomized Study Drug | Placebo, Radiation and Temozolomide (TMZ) | 337 | |
| Overall Study | Received Randomized Study Drug | Depatuxizumab Mafodotin, Radiation and TMZ | 344 | |
| Overall Study | Received Randomized Study Drug | Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ | 6 | |
| Overall Study | Entered Adjuvant Phase | Placebo, Radiation and Temozolomide (TMZ) | 285 | |
| Overall Study | Entered Adjuvant Phase | Depatuxizumab Mafodotin, Radiation and TMZ | 273 | |
| Overall Study | Entered Adjuvant Phase | Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ | 6 | |
| Overall Study | Entered Follow-Up Phase | Placebo, Radiation and Temozolomide (TMZ) | 328 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2,718
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 | Placebo, Radiation and TMZ: Chemoradiation Phase | 21 | 335 | 29 |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo, Radiation and TMZ: Adjuvant Phase | 14 | 285 | 21 |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo, Radiation and TMZ: Follow Up Phase | 0 | 326 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Depatuxizumab Mafodotin, Radiation and TMZ: Chemoradiation Phase | 15 | 342 | 23 |
| other | ANAEMIA | Blood and lymphatic system disorders | Depatuxizumab Mafodotin, Radiation and TMZ: Adjuvant Phase | 14 | 273 | 27 |
| other | ANAEMIA | Blood and lymphatic system disorders | Depatuxizumab Mafodotin, Radiation and TMZ: Follow Up Phase | 0 | 326 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Open-Label Depatuxizumab Mafodotin, Radiation and TMZ: Chemoradiation Phase | 0 | 6 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Open-Label Depatuxizumab Mafodotin, Radiation and TMZ: Adjuvant Phase | 1 | 6 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Open-Label Depatuxizumab Mafodotin, Radiation and TMZ: Follow Up Phase | 0 | 5 | 0 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Placebo, Radiation and TMZ: Chemoradiation Phase | 21 | 335 | 37 |
1 to 10 of 2,718Source ClinicalTrials.gov
See all 2,718 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo, Radiation and TMZ: Chemoradiation Phase | 4 | 335 |
| Total, all-cause mortality | Placebo, Radiation and TMZ: Adjuvant Phase | 13 | 285 |
| Total, all-cause mortality | Placebo, Radiation and TMZ: Follow Up Phase | 180 | 326 |
| Total, all-cause mortality | Depatuxizumab Mafodotin, Radiation and TMZ: Chemoradiation Phase | 4 | 342 |
| Total, all-cause mortality | Depatuxizumab Mafodotin, Radiation and TMZ: Adjuvant Phase | 22 | 273 |
| Total, all-cause mortality | Depatuxizumab Mafodotin, Radiation and TMZ: Follow Up Phase | 188 | 326 |
| Total, all-cause mortality | Open-Label Depatuxizumab Mafodotin, Radiation and TMZ: Chemoradiation Phase | 0 | 6 |
| Total, all-cause mortality | Open-Label Depatuxizumab Mafodotin, Radiation and TMZ: Adjuvant Phase | 0 | 6 |
| Total, all-cause mortality | Open-Label Depatuxizumab Mafodotin, Radiation and TMZ: Follow Up Phase | 1 | 5 |
| Total, other adverse events | Placebo, Radiation and TMZ: Chemoradiation Phase | 290 | 335 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers3
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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Verbal Learning | Secondary outcome |
Source ConductCognition
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/NCT02573324
GET https://conductscience.org/api/trials/v1/NCT02573324/events?page=2