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

Study Identifier
M13-813
CT.gov Identifier
NCT02573324
EudraCT Identifier
2015-001166-26
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
Available Language(s): English, Chinese (Simplified), Dutch, French, German, Portuguese (Native)
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Study Details

Medical Condition
  • Cancer - Other
    • Study Drug
  • Temozolomide
  • Depatuxizumab mafodotin
  • Placebo for ABT-414
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    St. Josephs Hospital and Med Center /ID# 144149
    Phoenix, Arizona, United States, 85013
    Status
    Not applicable
    Location
    Highlands Oncology Group, PA /ID# 142050
    Springdale, Arkansas, United States, 72762
    Status
    Not applicable
    Location
    University of Southern California /ID# 147543
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    University of California, Los Angeles /ID# 149239
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    Sharp Memorial Hospital /ID# 148193
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Univ California, San Francisco /ID# 145889
    San Francisco, California, United States, 94143-2204
    Status
    Not applicable
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