Summary

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

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)

Details

The main study for all countries except China is closed. The sub-study of ABT-414 (number of participants being sought=12) in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment is open to enrollment.

Keywords

Glioblastoma Multiforme 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 Glioblastoma Dacarbazine Mitogens Radiation ABT-414, radiation and TMZ

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 gliomatosis 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 /ID# 145889 in progress, not accepting new patients
    San Francisco California 94143-2204 United States
  • University of California, Los Angeles /ID# 149239 in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Cedars-Sinai Medical Ctr /ID# 148472 accepting new patients
    Los Angeles California 90048 United States
  • St. John's Health Center /ID# 148192 accepting new patients
    Santa Monica California 90404 United States

Lead Scientist

  • Nicholas Butowski
    Professor, Neurological Surgery. Authored (or co-authored) 88 research publications

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
Study Type
Interventional
Last Updated