Phase 3
N=691
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Glioblastoma · Gliosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT02573324 ↗Enrolled (actual)
691
Serious AEs
16.8%
Results posted
May 2023
Primary outcome: Primary: Overall Survival (OS) — 18.7; 18.9 months — p=0.633
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Temozolomide (Drug); Depatuxizumab mafodotin (Drug); Radiation (Radiation); Placebo for ABT-414 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
18.7; 18.9 | 0.633 |
| SECONDARY OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group |
16.2; 16.1 | 0.504 |
| SECONDARY OS for the MGMT Methylated Group |
NA; 25.4 | 0.773 |
| SECONDARY OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup |
18.2; 19.8 | 0.381 |
| SECONDARY Progression-Free Survival (PFS) |
6.3; 8.0 | 0.029 sig |
| SECONDARY PFS for EGFRvIII-Mutated Tumor Subgroup |
5.9; 8.3 | 0.002 sig |
| SECONDARY Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score |
11.0; 6.1 | 0.994 |
| SECONDARY Deterioration Free Survival in MDASI-BT Symptom Interference Score |
9.7; 6.1 | 0.938 |
| SECONDARY Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score |
13.2; 10.7 | 0.814 |
Summary
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.
Eligibility Criteria
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 participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment).
Exclusion Criteria
- Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the participant 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 Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.
Data sourced from ClinicalTrials.gov (NCT02573324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.