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

NCT02573324

Description:

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. The main study for all countries except China is closed. The sub-study of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment is open to enrollment.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

A Study of ABT-414 in Subjects With Newly Diagnosed <span class="go-doc-concept go-doc-disease">Glioblastoma</span> (GBM) With Epidermal Growth Factor Receptor (<span class="go-doc-concept go-doc-biomarker">EGFR</span>) <span class="go-doc-concept go-doc-keyword">Amplification</span>

Title

  • Brief Title: A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
  • Official Title: A Randomized, Placebo Controlled Phase 2b/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 (Intellance 1)
  • Clinical Trial IDs

    NCT ID: NCT02573324

    ORG ID: M13-813

    NCI ID: 2015-001166-26

    Trial Conditions

    Glioblastoma

    Gliosarcoma

    Trial Interventions

    Drug Synonyms Arms
    ABT-414 ABT-414, radiation and TMZ
    Temozolomide ABT-414, radiation and TMZ, Placebo, radiation and TMZ
    Placebo for ABT-414 Placebo, radiation and TMZ

    Trial Purpose

    This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy
    and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in
    participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor
    (EGFR) amplification.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    ABT-414, radiation and TMZ Experimental 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. ABT-414, Temozolomide
    Placebo, radiation and TMZ Placebo Comparator 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. Temozolomide, Placebo for ABT-414

    Eligibility Criteria

    Inclusion Criteria: 1. Must have a clinical diagnosis of Glioblastoma (GBM) 2. Must have a
    confirmed Epidermal growth factor receptor amplification in tumor tissue 3. Must have a
    Karnofsky Performance Status (KPS) performance score of 70 - 100.

    4. Must have recovered from effects of surgery, postoperative infection and other
    complications of surgery.

    5. Must have adequate bone marrow, renal, and hepatic function Exclusion Criteria: 1.
    Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri 2. Prior
    chemo therapy or radiosensitizer for head and neck cancer. 3. Prior radiotherapy to the
    head or neck in overlap of radiation fields. 4. Prior therapy for glioblastoma or other
    invasive malignancy. 5. Prior, concomitant or planned treatment with Novo-TTF,
    EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity
    anti-neoplastic therapy.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 99 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival (PFS) for Phase 2b

    Overall Survival (OS) for Phase 3

    Secondary Outcome Measures

    Progression Free Survival (PFS) for Phase 3

    Overall Survival (OS) for Phase 2b

    OS for the EGFRvIII-mutated tumor subgroup

    PFS for EGFRvIII-mutated tumor subgroup

    Number of days to deterioration in neurocognitive functioning

    Number of days to deterioration in symptom severity score M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT)

    Number of days to deterioration in symptom interference score (MDASI-BT)

    Trial Keywords

    Newly Diagnosed Glioblastoma

    Radiology Therapy Oncology Group

    Brain Tumor

    Brain Tumor Group

    Temozolomide

    ABT-414

    EGFRvIII

    Antibody Drug Conjugate

    Epithelial Growth Factor Receptor