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Eligibility
for people ages 18 years to 99 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in subjects with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.

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 (Intellance1)

Keywords

Glioblastoma Gliosarcoma Newly Diagnosed Glioblastoma Brain Cancer Temozolomide EGFR Amplified Radiology Therapy Oncology Group ABT-414 EGFRvIII Antibody Drug Conjugate Epithelial Growth Factor Receptor Brain Tumor Group First Line Therapy Brain Tumor Dacarbazine Mitogens

Eligibility

You can join if…

Open to people ages 18 years to 99 years

  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 (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

  • USC Norris Comprehensive Cancer Center and Hospital /ID# 147543 accepting new patients
    Los Angeles, California, 90033, USA
  • Cedars-Sinai Medical Center /ID# 148472 not yet accepting patients
    Los Angeles, California, 90048, USA
  • UCLA /Id# 149239 not yet accepting patients
    Los Angeles, California, 90095, USA
  • Sharp Memorial Hospital /ID# 148193 accepting new patients
    San Diego, California, 92123, USA
  • Providence St. John's Health Center /ID# 148192 accepting new patients
    Santa Monica, California, 90404, USA

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 2
Lead Scientist
Nicholas Butowski
Study Type
Interventional
Last Updated
April 2017
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