Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

Protocol: OSU-15251

Full Title

A Randomized, Placebo Controlled Phase IIb/III 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.

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.

Are you eligible?

Inclusion Criteria:

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Exclusion Criteria:

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Gliomas Brain Cancer