A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

Completed · Phase 3 · Has a placebo group

Conditions studied: Glioblastoma, Gliosarcoma

In brief

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.

Key facts

Study ID

NCT02573324

Run by

AbbVie

People needed

691

Starts

2015-01-04

Expected to finish

2022-04-04

Last updated by the study team

2023-05-11

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Highlands Oncology Group, PA /ID# 142050 — Springdale, Arkansas, United States
• University of Southern California /ID# 147543 — Los Angeles, California, United States
• University of California, Los Angeles /ID# 149239 — Los Angeles, California, United States
• Sharp Memorial Hospital /ID# 148193 — San Diego, California, United States
• Univ California, San Francisco /ID# 145889 — San Francisco, California, United States
• Duplicate_St. John's Health Center /ID# 148192 — Santa Monica, California, United States
• Cedars-Sinai Medical Center-West Hollywood /ID# 148472 — West Hollywood, California, United States
• Univ of Colorado Cancer Center /ID# 148194 — Aurora, Colorado, United States
• Associated Neurologists of Sou /ID# 147701 — Fairfield, Connecticut, United States
• Yale University /ID# 144170 — New Haven, Connecticut, United States
• Christiana Care Health Service /ID# 144127 — Newark, Delaware, United States
• Boca Raton Regional Hospital /ID# 163659 — Boca Raton, Florida, United States
• Holy Cross Hospital /ID# 156764 — Fort Lauderdale, Florida, United States
• Baptist Hospital Miami /ID# 152451 — Miami, Florida, United States
• Advent Health /ID# 144128 — Orlando, Florida, United States
• Moffitt Cancer Center /ID# 144130 — Tampa, Florida, United States
• Piedmont Hospital /ID# 145892 — Atlanta, Georgia, United States
• Emory Midtown Infectious Disease Clinic /ID# 144015 — Atlanta, Georgia, United States
• Northwestern University Feinberg School of Medicine /ID# 147895 — Chicago, Illinois, United States
• The University of Chicago Medical Center /ID# 144158 — Chicago, Illinois, United States
• NorthShore University HealthSystem /ID# 144017 — Evanston, Illinois, United States
• Northwestern Medicine Cancer Center - Warrenville /ID# 148476 — Warrenville, Illinois, United States
• Parkview Research Ctr, Hosp /ID# 144150 — Fort Wayne, Indiana, United States
• Univ Kansas Cancer Ctr - Overl /ID# 145895 — Westwood, Kansas, United States
• St. Josephs Hospital and Med Center /ID# 144149 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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