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 (Intellance 1)

Phase 3

Completed

Conditions: Glioblastoma
Grade 4 Brain tumor
10029211

Registration Number: NL-OMON47442

Lead Sponsor: AbbVie B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. de novo GBM tumors that test positive for EGFR ampflification.
2. Age >= 18 years.
3. Karnofsky performance status >= 70 <= 14 days prior to randomization.
4. Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
5. Adequate bone marrow, renal, and hepatic function <= 21 days prior to randomization.

Exclusion Criteria

1. multifocal, recurrent or metastic GBM.
2. prior chemo therapy or radiosensitizer for cancer of the head and neck region.
3. prior radiotherapy to the head or neck resulting in overlap of radiation fields.
4. prior therapy for glioblastoma except surgery or other invasive malignancy.
5. prior, concomitant or planned treatment with anti-neoplastic intent including but not limited to Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity antineoplastic therapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is: the overall survival (OS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- PFS<br /><br>- OS for the MGMT unmethylated group<br /><br>- OS for the MGMT methylated subgroup<br /><br>- OS in the sub group with EGFRvIII mutation<br /><br>- PFS in the sub group with EGFRvIII mutation<br /><br>- Time to deterioration in neurocognitive functioning on the Hopkins Verbal<br /><br>Learning Test Revised (HVLT-R)<br /><br>- Time to deterioration in symptom severity score according to M.d. Anderson<br /><br>Symptom Inventory Score, Brain Tumor Module (MDASI-BT)<br /><br>- Time to deterioration on symptom interference score (MDASI-BT)<br /><br>- Assessment of comparative safety<br /><br><br /><br>Explorative endpoints are:<br /><br>- OS after 1 year<br /><br>- OS after 2 years<br /><br>- PFS after 1 year<br /><br>- PFS after 2 years<br /><br>- More explorative endpoints about quality of life and neurocognitive function.</p><br>