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Active Clinical Trials

M13-813, Intellance 1

Active NCT:
02573324
Allegheny General Hospital
Allegheny General Hospital

Category:
Cancer - Brain
Sponsor: 
AbbVie
Contact: 

For more information, please contact Park Bogan at 412-359-6883 or Park.Bogan@ahn.org.

M13-813: 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)

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.

Ages Eligible for Study: 18 Years to 99 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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) performance score of 70 - 100.
  • Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
  • Must have adequate bone marrow, renal, and hepatic fuion

Exclusion Criteria:

  • Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri
  • 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-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.