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)
Description
Brief 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, this 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.
Phase
Phase 2/3 - for trials that are a combination of phases 2 and 3.Inclusion and Exclusion 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 (N/A to the sub-study)
- Must have recovered from effects of surgery, postoperative infection and other complications of surgery
- 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)
- 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 )
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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