A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Public ClinicalTrials.gov record NCT02573324. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.
Study identification
- NCT ID
- NCT02573324
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 691 participants
Conditions and interventions
Conditions
Interventions
- Temozolomide Drug
- Depatuxizumab mafodotin Drug
- Radiation Radiation
- Placebo for ABT-414 Drug
Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 4, 2015 (Actual)
- Primary completion
- Apr 4, 2022 (Actual)
- Completion
- Apr 4, 2022 (Actual)
- Last update posted
- May 11, 2023
2015 – 2022
United States locations
- U.S. sites
- 68
- U.S. states
- 29
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Josephs Hospital and Med Center /ID# 144149 | Phoenix | Arizona | 85013 | — |
| Highlands Oncology Group, PA /ID# 142050 | Springdale | Arkansas | 72762 | — |
| University of Southern California /ID# 147543 | Los Angeles | California | 90033 | — |
| University of California, Los Angeles /ID# 149239 | Los Angeles | California | 90095 | — |
| Sharp Memorial Hospital /ID# 148193 | San Diego | California | 92123 | — |
| Univ California, San Francisco /ID# 145889 | San Francisco | California | 94143-2204 | — |
| Duplicate_St. John's Health Center /ID# 148192 | Santa Monica | California | 90404 | — |
| Cedars-Sinai Medical Center-West Hollywood /ID# 148472 | West Hollywood | California | 90048 | — |
| Univ of Colorado Cancer Center /ID# 148194 | Aurora | Colorado | 80045 | — |
| Associated Neurologists of Sou /ID# 147701 | Fairfield | Connecticut | 06824 | — |
| Yale University /ID# 144170 | New Haven | Connecticut | 06510 | — |
| Christiana Care Health Service /ID# 144127 | Newark | Delaware | 19713 | — |
| Boca Raton Regional Hospital /ID# 163659 | Boca Raton | Florida | 33486 | — |
| Holy Cross Hospital /ID# 156764 | Fort Lauderdale | Florida | 33308 | — |
| Baptist Hospital Miami /ID# 152451 | Miami | Florida | 33176 | — |
| Advent Health /ID# 144128 | Orlando | Florida | 32803 | — |
| Moffitt Cancer Center /ID# 144130 | Tampa | Florida | 33612-9416 | — |
| Piedmont Hospital /ID# 145892 | Atlanta | Georgia | 30309 | — |
| Emory Midtown Infectious Disease Clinic /ID# 144015 | Atlanta | Georgia | 30322 | — |
| Northwestern University Feinberg School of Medicine /ID# 147895 | Chicago | Illinois | 60611-2927 | — |
| The University of Chicago Medical Center /ID# 144158 | Chicago | Illinois | 60637-1443 | — |
| NorthShore University HealthSystem /ID# 144017 | Evanston | Illinois | 60201 | — |
| Northwestern Medicine Cancer Center - Warrenville /ID# 148476 | Warrenville | Illinois | 60555 | — |
| Parkview Research Ctr, Hosp /ID# 144150 | Fort Wayne | Indiana | 46805 | — |
| Univ Kansas Cancer Ctr - Overl /ID# 145895 | Westwood | Kansas | 66205-2003 | — |
| Maine Medical Partners Neurolo /ID# 160864 | Scarborough | Maine | 04074 | — |
| Tufts Medical Center /ID# 145897 | Boston | Massachusetts | 02111-1552 | — |
| Massachusetts General Hospital /ID# 144145 | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute /ID# 148475 | Boston | Massachusetts | 02215 | — |
| Wayne State University /ID# 145890 | Detroit | Michigan | 48201-2013 | — |
| Henry Ford Health System /ID# 145896 | Detroit | Michigan | 48202 | — |
| Duplicate_St. Joseph Mercy Hospital /ID# 144143 | Ypsilanti | Michigan | 48197 | — |
| Mmcorc /Id# 144146 | Saint Louis Park | Minnesota | 55416 | — |
| Washington University-School of Medicine /ID# 144174 | St Louis | Missouri | 63110 | — |
| Nebraska Methodist Hospital /ID# 144140 | Omaha | Nebraska | 68114 | — |
| University of Nebraska Medical Center /ID# 145899 | Omaha | Nebraska | 68198 | — |
| MD Anderson Cancer Center at Cooper - Camden /ID# 145891 | Camden | New Jersey | 08103 | — |
| Rutgers Cancer Institute of New Jersey /ID# 148190 | New Brunswick | New Jersey | 08901 | — |
| Columbia University Medical Center /ID# 144020 | New York | New York | 10032-3729 | — |
| University of Rochester Medical Center /ID# 144166 | Rochester | New York | 14642 | — |
| Levine Cancer Ins, Carolina Me /ID# 144124 | Charlotte | North Carolina | 28204 | — |
| University of Cincinnati /ID# 144164 | Cincinnati | Ohio | 45267-0585 | — |
| Duplicate_Univ Hosp Cleveland /ID# 144153 | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Main Campus /ID# 144023 | Cleveland | Ohio | 44195 | — |
| The Ohio State University /ID# 144016 | Columbus | Ohio | 43210 | — |
| University of Toledo /ID# 156763 | Toledo | Ohio | 43614 | — |
| Univ Oklahoma HSC /ID# 144161 | Oklahoma City | Oklahoma | 73104 | — |
| St. Luke's Hospital /ID# 148191 | Bethlehem | Pennsylvania | 18017 | — |
| Penn State University and Milton S. Hershey Medical Center /ID# 147525 | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania /ID# 157623 | Philadelphia | Pennsylvania | 19104-5502 | — |
| Thomas Jefferson University /ID# 144191 | Philadelphia | Pennsylvania | 19107-4414 | — |
| Fox Chase Cancer Center /ID# 145893 | Philadelphia | Pennsylvania | 19111 | — |
| Allegheny General Hospital /ID# 144126 | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pennsylvania Medical Center - Shadyside /ID# 144159 | Pittsburgh | Pennsylvania | 15232 | — |
| Medical University of South Carolina /ID# 144141 | Charleston | South Carolina | 29425 | — |
| Austin Cancer Centers /ID# 151061 | Austin | Texas | 78758 | — |
| Baylor Sammons Cancer Center /ID# 155542 | Dallas | Texas | 75246 | — |
| The University of Texas Health Science Center at Houston /ID# 144013 | Houston | Texas | 77030 | — |
| University of Texas MD Anderson Cancer Center /ID# 144018 | Houston | Texas | 77030 | — |
| Duplicate_Scott and White Medical Center /ID# 160743 | Temple | Texas | 76508 | — |
| Intermountain Medical Center /ID# 144142 | Murray | Utah | 84107-5701 | — |
| University of Utah /ID# 144160 | Salt Lake City | Utah | 84112-5500 | — |
| Inova Health System /ID# 152956 | Falls Church | Virginia | 22042 | — |
| Virginia Commonwealth University Medical Center Main Hospital /ID# 149014 | Richmond | Virginia | 23219 | — |
| Virginia Mason Medical Center /ID# 144022 | Seattle | Washington | 98101 | — |
| University of Washington /ID# 144162 | Seattle | Washington | 98109 | — |
| Univ of Wisconsin Hosp/Clinics /ID# 144167 | Madison | Wisconsin | 53792-0001 | — |
| Froedtert Memorial Lutheran Hospital /ID# 144139 | Milwaukee | Wisconsin | 53226-3522 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 144 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02573324, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 11, 2023 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02573324 live on ClinicalTrials.gov.