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Summary

for people ages 18–99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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)

Keywords

Glioblastoma Gliosarcoma 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 Dacarbazine Mitogens

Eligibility

You can join if…

Open to people ages 18–99

  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) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study).
  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 (For the sub-study, the subject must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment)

You CAN'T join if...

  1. 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)
  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

Locations

  • Univ California, San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • UCLA accepting new patients
    Los Angeles, California, 90095, United States
  • Cedars-Sinai Medical Ctr accepting new patients
    Los Angeles, California, 90048, United States
  • St. John's Health Center accepting new patients
    Santa Monica, California, 90404, United States
  • USC accepting new patients
    Los Angeles, California, 90033, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
can search for the study and find research centers participating
ID
NCT02573324
Phase
Phase 3
Lead Scientist
Nicholas Butowski
Study Type
Interventional
Last Updated
January 15, 2018
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