A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
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ClinicalTrials.gov Identifier: NCT02573324 |
Recruitment Status :
Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : July 12, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
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Glioblastoma Gliosarcoma | Drug: Temozolomide Drug: ABT-414 Radiation: Radiation Drug: Placebo for ABT-414 | Phase 2 Phase 3 |
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 691 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | December 7, 2015 |
Estimated Primary Completion Date : | July 18, 2020 |
Estimated Study Completion Date : | July 18, 2020 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo, radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 & 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
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Drug: Temozolomide
oral Radiation: Radiation Drug: Placebo for ABT-414 intravenous infusion |
Experimental: ABT-414, radiation and TMZ
ABT-414 is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. ABT-414 is given on Day 1 & 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
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Drug: Temozolomide
oral Drug: ABT-414 intravenous infusion
Other Names:
Radiation: Radiation |
- Overall Survival (OS) [ Time Frame: Quarterly after treatment discontinuation for approximately 4 years ]Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must have a clinical diagnosis of Glioblastoma (GBM)
- Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue
- Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study).
- Must have recovered from effects of surgery, postoperative infection and other complications of surgery
- Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the subject must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment)
Exclusion Criteria:
- Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the sub-study, the subject can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM)
- Prior chemo therapy or radiosensitizer for head and neck cancer
- Prior radiotherapy to the head or neck in overlap of radiation fields
- Prior therapy for glioblastoma or other invasive malignancy
- Prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573324

Study Director: | AbbVie Inc. | AbbVie |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT02573324 History of Changes |
Other Study ID Numbers: |
M13-813 2015-001166-26 ( EudraCT Number ) |
First Posted: | October 9, 2015 Key Record Dates |
Last Update Posted: | July 12, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. |
Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. |
URL: | https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Newly Diagnosed Glioblastoma Epithelial Growth Factor Receptor (EGFR) Temozolomide ABT-414 Radiology Therapy Oncology Group Antibody Drug Conjugate |
Brain Tumor Brain Tumor Group EGFRvIII EGFR Amplified First Line Therapy Brain Cancer |
Glioblastoma Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Temozolomide Mitogens Immunoconjugates Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Immunologic Factors Physiological Effects of Drugs |